K202551 · Lsi Solutions, Inc. · GCJ · Jun 24, 2021 · Gastroenterology, Urology
Device Facts
Record ID
K202551
Device Name
Cor-Knot Micro
Applicant
Lsi Solutions, Inc.
Product Code
GCJ · Gastroenterology, Urology
Decision Date
Jun 24, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.
Device Story
The COR-KNOT MICRO is a sterile, single-use, hand-operated surgical instrument designed to secure polypropylene sutures during soft tissue approximation. The device is preloaded with a medical-grade titanium fastener. In operation, the surgeon threads suture ends through a wire snare within the device tip and into the titanium fastener. Squeezing the device's purple lever activates a hammer-anvil mechanism that crimps the fastener onto the suture and trims excess suture tails. A yellow lever stop prevents accidental firing before use. The device allows for ergonomic orientation of suture tails via a rotating handle. It is intended for use in open or minimally invasive surgical procedures. By providing a secure, automated alternative to manual knot-tying, the device facilitates efficient wound closure and hemostasis. The device is not intended for reloading or reuse.
Clinical Evidence
No clinical data. Evidence consists of bench testing and an acute in vivo animal study (pig model). Bench testing verified fastener security, KPA force exceeding USP standards, and durability under simulated hypertensive pulsatile conditions (up to 360/240 mmHg) for 6 weeks. Animal study demonstrated superior or equivalent performance in wound approximation, hemostasis, and burst strength compared to hand-tied knots.
Technological Characteristics
Single-use, non-powered, hand-operated delivery device. Materials: medical-grade titanium fastener, polymer handle/shaft. Mechanism: hammer-anvil crimping and integrated suture cutter. Dimensions: designed for superficial and minimally invasive access. Sterilization: Ethylene Oxide (minimum 10^-6 lethality). Biocompatibility: conforms to ISO 10993-1:2018. Packaging: PETG tray with Tyvek/nylon pouch, ISO 11607-1 compliant.
Indications for Use
Indicated for the approximation of soft tissue using USP 6-0, 7-0, or 8-0 polypropylene surgical suture.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2021
LSI Solutions, Inc. Christopher Miller Executive Director of Regulatory Affairs and Quality 7796 Victor-Mendon Road Victor, New York 14564
Re: K202551
Trade/Device Name: Cor-Knot Micro Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 2, 2020 Received: September 3, 2020
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K202551
Device Name COR-KNOT MICRO™
Indications for Use (Describe)
The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary
| Submitted By: | LSI SOLUTIONS, Inc. |
|----------------------------|------------------------------------------------------------------|
| | 7796 Victor-Mendon Road |
| | Victor, NY 14564 |
| | |
| Contact Person: | Christopher B. Miller |
| | Executive Director of Regulatory Affairs and Quality |
| | Phone: (585) 869-6665 |
| | Fax: (585) 742-8086 |
| | Email: cmiller@lsisolutions.com |
| | |
| Date Prepared: | September 2, 2020 (updated June 23, 2021) |
| | |
| Trade Name: | COR-KNOT MICRO™ |
| | |
| Common Name: | Knot tying device |
| | |
| Classification Name: | Accessory to an endoscope (per 21 CFR 876.1500); and |
| | Manual Surgical Instrument for General Use (per 21 CFR 878.4800) |
| | |
| Classification Regulation: | 21 CFR 876.1500 (Per the higher classification) |
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K202551 Page 2 of 9
Product Code: GCJ (which is reviewed by the General and Plastic Surgery Panel)
Device Classification: Class II
Predicate Device: TK® Ti-KNOT® Device
## Device Description
The COR-KNOT MICRO™ Device is a sterile, single patient use device provided to the user preloaded with a single COR-KNOT MICRO™ fastener. Made from medical grade titanium, the COR-KNOT MICRO™ fastener is a hollow sleeve with a rounded base. A white plastic target holds the loop shape of a wire snare. The wire snare passes through the COR-KNOT MICRO™ fastener and is attached to a snare puller knob. A suture slot in the device shaft lies under the opening in the snare puller. The ends of a USP 6-0, 7-0, or 8-0 polypropylene suture are passed through the wire snare and subsequently threaded into the titanium fastener. The snare puller attached to its wire snare is pulled up along the device shaft until it snaps onto the puller retainer feature of the purple knob, which also has an integrated indicator fin. The suture slot and the indicator fin are located on the same side of the device shaft. The subsequently crimped fastener and remnant trimmed suture tails bend slightly in the direction away from or opposite from the suture slot and indicator fin. By rotating the purple knob and the device's white handle, the surgeon can ergonomically orient the direction of the suture tails, if desired. A yellow lever stop is located behind the purple lever to restrict inadvertent squeezing of the lever during device handling before crimping. The lever stop is removed by pinching its sides together and pulling it out of the handle. By squeezing the purple lever, the COR-KNOT MICRO™ Device crimps the
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COR-KNOT MICRO™ fastener to fasten together segments of suture and trims away excess suture.
One COR-KNOT MICRO™ Device is provided per package, and the COR-KNOT MICRO™ Device is not intended to be reloaded or reused.
The COR-KNOT MICRO™ device is intended for use in the approximation of soft tissue.
# Indications for Use
The COR-KNOT MICRO™ device with COR-KNOT MICRO™ fastener when used in conjunction with USP 6-0, 7-0, or 8-0 polypropylene surgical suture, is indicated for use in the approximation of soft tissue.
## Technological characteristics (comparison to Predicate Device)
Both the predicate Ti-KNOT® device and the subject COR-KNOT MICRO™ device have the same intended use: "Intended for use in the approximation of soft tissue." The predicate Ti-KNOT® device is "indicated for use in the approximation of soft tissue", and LSI recommends its use with 2-0 polypropylene suture, among other suture types. The subject COR-KNOT MICRO™ device has very similar indications. The COR-KNOT MICRO™ device, when used with USP 6-0, 7-0, and 8-0 polypropylene suture is also "indicated for use in the approximation of soft tissue." While the predicate and subject devices are each optimized for securing different types of suture, they operate on identical technical principles. Both devices are single use, nonpowered, hand operated devices which incorporate a hammer-anvil mechanism that crimps a
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Summary K202551 23 JUN 2021
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K202551 Page 4 of 9
titanium fastener held in the device tip onto suture previously snared through the fastener. Both devices also trim away excess suture tails.
Knot pull apart (KPA) force is a key performance requirement for both subject and predicate devices. Both the predicate Ti-KNOT® device and the subject COR-KNOT MICRO™ device exceed the USP KPA specifications for their compatible suture. Both the predicate and subject devices are provided sterile and are sterilized with Ethylene Oxide such that a minimum lethality of 10 ° is achieved. The predicate Ti-KNOT® device is a stainless steel and polymer delivery device with a titanium fastener. The COR-KNOT MICRO™ device is made from identical materials for the delivery device and the fastener. Both devices conform to the requirements of ISO 10993. The predicate device is packaged in a rigid thermoformed blister tray with a Tyvek cover. The subject device is comparably packaged in a PETG tray and snap retainer lid that is sealed in a Tyvek/nylon pouch.
The COR-KNOT MICRO™ device and the predicate Ti-KNOT® device are substantially equivalent. The differences between the subject and predicate devices are largely related to size, their function is comparable, and the differences do not introduce any new risks and have no negative impact on the safety and efficacy of the device.
# Performance Testing Summary
Bench top performance testing was conducted to verify that the COR-KNOT MICRO™ device will perform as intended and to ensure the device will perform equivalently to the predicate
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device. The following non-clinical tests were conducted, and all results met the performance and risk-based acceptance criteria:
● Functional Verification and Validation Testing to ensure the following Design Input Requirements were met:
- A Fastener must secure 6-0. 7-0 and 8-0 polypropylene suture with knot pull apart (KPA) forces exceeding USP standards.
- Fastener shall not be damaged prior to deployment. A
- > Device shall retain fastener prior to crimping/cutting without the fastener dislodging from the tip of the device.
- Releasing the crimped fastener from the device, shall not damage the fastener. >
- > The device shall cut the suture after a completed crimp.
- > Crimped fastener shall not cause more damage to anatomy than hand tied suture/knots.
- > The device shall be compatible with only COR-KNOT MICRO™ fasteners.
- > System compatible with 6-0, 7-0, and 8-0 sized polypropylene sutures.
- > The device will prevent reloading in the field.
- > Inserted shaft length shall be comparable to other related surgical devices demonstrated to reach superficial surgical access sites and most open and minimally invasive surgical site locations.
- > Device shall allow for surgical site visibility.
- Inserted portion of device and entirety of fastener shall be shaped to reduce risk of > tissue damage or other iatrogenic injury.
- The device and fastener must function with exposure to typical surgical conditions. A
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- A Device must be capable of firing the single fastener provided with the device. If multiple fasteners are required within a case, multiple devices must be used.
- A The device shall allow suture to be easily loaded through the titanium fastener and distal end of the device.
- A The user must be able to remove Lever Stop prior to use of the device.
- A The user must be able to crimp a fastener with one hand.
- > The device shall not cause harm to the user.
- Biocompatibility per ISO 10993-1:2018. ●
- Packaging/Shelf-life Testing per ISO 11607-1 demonstrating a 3 year shelf life.
Additional bench testing involving a custom malignant hypertension pressure simulator successfully demonstrated the excellent strength and stability of COR-KNOT MICRO™ titanium fasteners on large diameter pulsatile tubular structures, mimicking extreme, supraphysiologic conditions during a simulated protracted healing period. This worst-case durability experiment incorporated supraphysiologic pressure waves mimicking systolic and diastolic pressure conditions more than 3x greater (>360/240 mmHg arterial blood pressure) than normal blood pressure in a human patient (120/80 mmHg). The pulsatile rate was also 25% faster, at 90 pulses per minute, than a normal rate, which is typical cited at 72 beats per minute. The experiment was conducted over a 6 week period to exceed the normal healing duration by a factor of 2–3x. All 60 COR-KNOT MICRO™ titanium fasteners used to secure 6-0, 7-0, and 8-0 polypropylene suture held without compromise throughout this protracted simulated healing period, despite being exposed to conditions beyond the physiologic worst case. For the duration of the six week test, all of the COR-KNOT MICRO™ titanium fasteners successfully secured simple interrupted
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K202551 Page 7 of 9
6-0, 7-0, and 8-0 sutures to close 8 Fr dilated wounds (consistent with the predicate device in vivo study) in simulation chambers utilizing pulsatile segments of latex tubing, which has an unpressurized diameter of 2.22 cm (7/8 in) and a wall thickness of 1.59 mm (1/16 in), to simulate aortic tissue within the human circulatory system.
The worst-case physiologic scenario in this test included several elements. The worst-case wound repair method was a simple interrupted suture, which used the lowest minimum number of strands through tissue to hold wound edges together. Thus, the force exerted on this single loop of suture, and the titanium fastener securing it, is higher than when multiple suture strands are incorporated at the same wound closure site. The worst-case suture size regarding titanium fastener holding force was the smallest diameter suture tested. The size of tissue structures routinely sutured with 6-0, 7-0, and 8-0 polypropylene is generally smaller than the human femoral artery, which is typically less than 10 mm in diameter. The worst-case tissue type was a large artery in a hypertensive patient who is tachycardic and slow to heal. The diameter of the tissue simulated in this experiment was ~30 mm. This simulation experiment also provided a sustained physiologic worst-case blood pressure of >360/240 mmHg over 6 weeks, which would be nonsurvivable in a patient. A worst-case healing time of 6 weeks was selected, which is several times greater than the 2–3 week period during which wounds would be expected to heal. Additionally, the pulsatile pattern simulating heart rate in this experiment (90 pulses per minute, ppm) was 25% more ppm than the typical human heart rate of 72 beats per minute (bpm). At a pulse rate of 90 bpm and an experimental duration of 6 weeks, 1 day, 3 hours, and 33 minutes (62,133 minutes), each wound closure experienced 5,591,970 distinct hypertensive pulses. The 60 COR-KNOT MICRO™ titanium fasteners--20 each for 6-0, 7-0, and 8-0 polypropylene
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K202551 Page 8 of 9
suture-experienced a total cumulative 335,518,200 distinct hypertensive pulses without any compromise.
This study confirmed that the COR-KNOT MICRO™ Device and its titanium fastener have the ability to secure and maintain closure of 6-0, 7-0, and 8-0 polypropylene suture under physiologic worst-case conditions over protracted healing time while being exposed to continuous pulsatile forces—384.6 mmHg average systolic pressure and 259.1 mmHg average diastolic pressure—beyond the stresses anticipated on the product under conditions of the clinically relevant worst-case scenario. The COR-KNOT MICRO™ Device and its titanium fastener successfully met all predetermined requirements and acceptance criteria defined for retention testing of the titanium fastener.
LSI also conducted an acute animal study to evaluate the safety and effectiveness of the proposed COR-KNOT MICRO™ Device and preloaded micro titanium fastener relative to a comparative study conducted in 1995 for the predicate device. The test report for the animal study compares the COR-KNOT MICRO™ Device in the worst-case size blood vessels to hand tied knots under the same conditions. The COR-KNOT MICRO™ titanium fastener provided superior or equivalent—and never inferior—results for ease of use, wound approximation, hemostasis, burst strength, and tensile strength as compared to the controls. Results and observations from the animal procedure tests demonstrate that the COR-KNOT MICRO™ Device with its titanium fastener is easy to use and provides excellent wound approximation resulting in hemostasis in conjunction with 6-0, 7-0, and 8-0 polypropylene suture. Overall, this study confirmed that the COR-KNOT MICRO™ Device and its titanium fastener have the ability
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K202551 Page 9 of 9
to hemostatically secure and maintain closure of wounds using 6-0, 7-0, and 8-0 polypropylene suture in an acute in vivo pig model; harvested specimens were tested and demonstrated burst strengths beyond supraphysiologic worst case anticipated conditions.
## Clinical testing
Not applicable. Neither the predicate product nor the subject product require clinical testing since the performance of this product is to hold the suture that holds tissue (but not directly the tissue itself). The reliability and excellent performance of this product has been sufficiently demonstrated in multiple experiments that do not require clinical testing in patients.
#### Substantial Equivalence
The subject device and predicate device have the same intended use and technological characteristics. Non-clinical performance data has demonstrated the subject device is substantially equivalent to the predicate device.
#### In Conclusion
Extensive testing demonstrates the proposed COR-KNOT MICRO™ product consistently provides excellent suture holding security for 6-0. 7-0. and 8-0 polypropylene suture and can be dependably manufactured. The subject COR-KNOT MICRO™ device and titanium fastener are substantially equivalent to the predicate Ti-KNOT® device, K981531.
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Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
