K222170 · Health Line International Corporation · NIE · Jan 13, 2023 · Gastroenterology, Urology
Device Facts
Record ID
K222170
Device Name
Power Acute Triple Lumen Hemodialysis Catheter
Applicant
Health Line International Corporation
Product Code
NIE · Gastroenterology, Urology
Decision Date
Jan 13, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5540
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Power Acute Triple Lumen Hemodialysis Catheter is intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Device Story
Thermally reactive polyurethane triple-lumen catheter; rigid at room temperature for bedside insertion; softens at body temperature to minimize vein perforation risk. Features radiopaque cannula with incremental markings; three independent non-communicating lumens; luer-fitted silicone extension legs; color-coded occlusion clamps (red/arterial, blue/venous, purple/medial). Distal end thermally bonded to symmetrically tapered tip with skived side openings. Used by clinicians for short-term central venous access via Seldinger technique in internal jugular, subclavian, or femoral sites. Enables hemodialysis, apheresis, infusion, pressure monitoring, and power injection of contrast media. Output is fluid delivery or withdrawal; clinical decision-making relies on catheter patency and flow performance. Benefits include improved patient comfort and procedural efficiency.
Clinical Evidence
Bench testing only. No clinical data. Performance evaluated via ISO 11135 (sterilization), ISO 11607-1 (shelf life), and ISO 10993-1 (biocompatibility). Functional testing included air/liquid leakage, tensile strength, flow rate, priming volume, kinking, repeated clamping, luer fitting, chemical tolerance, power injection performance, static burst pressure, recirculation rate, and pressure vs. flow rate.
Indicated for short-term central venous access in adults for hemodialysis, apheresis, infusion, central venous pressure monitoring, and power injection of contrast media (max 5 mL/sec).
Regulatory Classification
Identification
A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device. (2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle). (3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
Special Controls
*Classification.* (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
*1* ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
*2* ) Proper care and maintenance of the device and device exit site;(
*3* ) Removal of the device;(
*4* ) Anticoagulation;(
*5* ) Management of obstruction and thrombus formation; and(
*6* ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
January 13, 2023
Health Line International Corporation Aaron Faulkner Vice-President, Quality Assurance and Regulatory Affairs 260 North Ace Yeager Court, Unit D Salt Lake City, Utah 84116
Re: K222170
Trade/Device Name: Power Acute Triple Lumen Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: NIE Dated: December 14, 2022 Received: December 15, 2022
Dear Aaron Faulkner:
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
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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 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 medical devices and radiation-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,
# Gema Gonzalez -S
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222170
Device Name
Power Acute Triple Lumen Hemodialysis Catheter
Indications for Use (Describe)
The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring and pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
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| SUBMITTER | Name:<br>Address:<br>FDA Registration #:<br>Contact Name:<br>Telephone:<br>Fax:<br>Email:<br>Date Prepared: | Health Line International Corporation<br>260 North Ace Yeager CT, Unit D<br>Salt Lake City, Utah 84116<br>USA<br>3010882065<br>Aaron G. Faulkner<br>Vice-President, Quality Assurance and Regulatory<br>Affairs<br>801-773-7798 Ext. 109<br>855-228-1336<br>agfaulkner@hlic.net<br>July 19, 2022 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBJECT<br>DEVICE | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number: | Power Acute Triple Lumen Hemodialysis Catheter<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540 |
| PREDICATE<br>DEVICE | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number:<br>Recall Event ID: | Mahurkar™ Triple Lumen Dialysis Catheter<br>(K102605) by Covidien, LLC<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540<br>82802 |
| REFERENCE<br>DEVICE A | Name:<br>Regulation Name:<br>Classification Name:<br>Classification Panel:<br>Regulatory Class:<br>Product Code:<br>Regulation Number: | Power-Trialysis™ Slim-Cath™ Short-Term Dialysis<br>Catheter (K141531) by C.R. Bard, Inc.<br>Blood access device and accessories<br>Catheter, Hemodialysis, Triple Lumen, Non-<br>Implanted<br>Gastroenterology/Urology<br>Class II<br>NIE<br>21 CFR 876.5540 |
| Recall Event ID: | No recall has been issued to K141531 | |
| Name: | Acute Dual Lumen Hemodialysis Catheter (K200426)<br>by Health Line International Corporation | |
| Regulation Name: | Blood access device and accessories | |
| REFERENCE<br>DEVICE B | Classification Name: | Catheter, Hemodialysis, Non-Implanted |
| | Classification Panel: | Gastroenterology/Urology |
| | Regulatory Class: | Class II |
| | Product Code: | MPB |
| | Regulation Number: | 21 CFR 876.5540 |
| Recall Event ID: | No recall has been issued to K200426 | |
510(k) SUMMARY (21 CFR 807.92)
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K222170 Page 2 of 6
DEVICE
DESCRIPTION
510(k) Premarket Notification Submission: Power Acute Triple Lumen Hemodialysis Catheter
The Power Acute Triple Lumen Hemodialysis Catheter is manufactured from a thermally reactive polyurethane material known for its rigidity at room temperature and softness at body temperature. This reactivity allows bedside insertion, while minimizing the risk of vein perforation and providing an overall improvement of patient comfort after insertion. The catheter cannula is radiopaque and incrementally marked to indicate the effective insertion length of the device in centimeters (cm). This cannula is extruded with three independent, non-communicating inner lumens. The lumens are made accessible within the cannula via luer-fitted silicone extension legs on the proximal end of the device, alongside a rigid polyurethane hub marked with the catheter's size in French (Fr) and effective insertion length that is fitted with a freely rotating suture wing. The clear outer extension legs are fitted with red and blue occlusion clamps, which are marked on either face with the lumen's priming volume in milliliters (mL), and respectively identify arterial and venous lumens. The medial, colored, extension leg is fitted with a purple occlusion clamp that is similarly marked with priming volume on its dorsal face, and marked with the maximum flow rate (in cubic centimeters [cc]) and injection pressure (in pounds per square inch [psi]) recommended for power-injected fluids on its ventral face. The distal end of the device is thermally bonded to a flexible, symmetrically tapered tip, which allows for direct outflow, and is skived on the radial and ulnar sides of the cannula.
The size configuration for the Power Acute Triple Lumen Hemodialysis Catheter is shown in the following table.
| SUBJECT DEVICE CONFIGURATION | | | | | |
|------------------------------|-------------|----|----|----|----|
| SIZE (Fr) | LENGTH (cm) | | | | |
| 12 | 12 | 15 | 20 | 24 | 30 |
The Power Acute Triple Lumen Hemodialysis Catheter is intended for short INTENDED USE term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media. The
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maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
#### The Power Acute Triple Lumen Hemodialysis Catheter is indicated for short term central venous access for hemodialysis, apheresis, infusion, central INDICATIONS venous pressure monitoring, and pressure injection of contrast media. The FOR USE maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.
Subject Device: Power Acute Triple Lumen Hemodialysis Catheter Predicate Device: Mahurkar™ Triple Lumen Dialysis Catheter (K102605)
| | ATTRIBUTES | SUBJECT DEVICE | PREDICATE DEVICE | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| TECHNOLOGICAL<br>CHARACTERISTICS | Intended use | The Power Acute Triple<br>Lumen Hemodialysis<br>Catheter is intended for<br>short term central<br>venous access for<br>hemodialysis, apheresis,<br>infusion, central venous<br>pressure monitoring,<br>and pressure injection<br>of contrast media. The<br>maximum<br>recommended infusion<br>rate is 5 mL/sec for<br>power injection of<br>contrast media. | The Mahurkar™ Triple<br>Lumen Dialysis<br>Catheter is intended<br>for short term central<br>venous access for<br>hemodialysis,<br>apheresis, infusion,<br>central venous<br>pressure monitoring<br>and pressure injection<br>of contrast media. The<br>maximum<br>recommended infusion<br>rate is 5 mL/sec for<br>power injection of<br>contrast media. | | |
| | | | Intended duration | Short term (< 30 days) | Short term (< 30 days) |
| | | | Intended treatment | Acute condition | Acute condition |
| | | | Prescription device | Yes | Yes |
| | | | Insertion sites | Internal jugular<br>Subclavian<br>Femoral | Internal jugular<br>Subclavian<br>Femoral |
| | | | Insertion technique | Seldinger (Over the<br>guidewire) | Seldinger (Over the<br>guidewire) |
| | | | Intended<br>population | Adults | Adults |
| | | | Catheter size | 12 Fr | 12 Fr |
| | | | Catheter OD | 4.20 mm | 4.15 mm |
| | Catheter lengths<br>available (cm) | 12, 15, 20, 24, 30 | 13, 16, 20, 24 | | |
| | Catheter length for<br>comparison | 24 cm | 24 cm | | |
| | | | | | |
| Catheter shaft effective length | 24 cm | 24 cm | | | |
| Insertion markings | Every centimeter | None | | | |
| Catheter shaft material | Polyurethane | Polyurethane | | | |
| Catheter/Extension configuration | Straight Extensions<br>Curved Extensions | Straight Extensions<br>Curved Extensions | | | |
| Catheter cuffed | No | No | | | |
| Tip design | Symmetrical soft tapered tip | Symmetrical soft tapered tip | | | |
| Tip placement | The distal tip should be located just before the junction of the superior vena cava and the right atrium | The distal tip should be located just before the junction of the superior vena cava and the right atrium | | | |
| Number of lumens | 3 | 3 | | | |
| Lumen identification | Color coded clamps:<br>Red (Arterial)<br>Blue (Venous)<br>Purple (Medial) | Color coded luer connectors:<br>Red (Arterial)<br>Blue (Venous)<br>Clear (Medial) | | | |
| Extension legs (Venous, Arterial) | Silicone | Silicone | | | |
| Extension leg (Medial) | Polyurethane | Polyurethane | | | |
| Cross-section geometry | Modified Double “D” with Center Lumen | Modified Double “D” with Off-Center Lumen | | | |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | | | |
| Method of use | Single use | Single use | | | |
| Shelf life | 3 years | 5 years | | | |
| Primary packaging | Tyvek Tray | Tyvek Tray | | | |
| Catheter side openings | 4 holes | 2 holes<br>1 slot | | | |
| Luer Connectors | ISO 594-1 Compatible | ISO 594-1 Compatible | | | |
| Non-Pyrogenic | Yes | Yes | | | |
| Made with latex rubber | No | No | | | |
| Made with DEHP | No | No | | | |
| Power Injection (PI) | Yes | Yes | | | |
| Max PI infusion rate | 5 mL/sec | 5 mL/sec | | | |
| Max PI pressure | 300 psi | 300 psi | | | |
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510(k) Premarket Notification Submission: Power Acute Triple Lumen Hemodialysis Catheter
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The subject device has similar technological characteristics as compared to the predicate device. Differences, if any, are not critical to the intended use of the subject device (see Section 12.7, Substantial Equivalence Discussion) and do not raise new questions regarding safety and effectiveness.
The Power Acute Triple Lumen Hemodialysis Catheter followed verification and validation activities in accordance with Design Controls as per 21 CFR Section 820.30.
Bench testing was conducted in accordance with FDA-recognized consensus standards to evaluate the performance of the subject device on:
- Air Leakage -
- Liquid Leakage -
- Tensile Strength -
- Catheter Flow Rate -
- Priming Volume -
- -Kinking
-
-
- Repeated Clamping -
- Conical Luer Lock Fittings -
- -Surface Appearance
- Chemical Tolerance -
- Power Injection Performance -
- Static Burst Pressure -
## SAFETY AND PERFORMANCE
- Recirculation Rate Central Venous Pressure Monitoring -
Pressure vs Flow Rate
- TESTING
Functional testing was conducted in accordance with ISO 11135 and ISO 11607-1 to evaluate sterilization and shelf life of the subject device.
Biocompatibility testing and assessment was conducted in accordance with ISO 10993-1 to evaluate the subject device on:
- Cytotoxicity -
- -Sensitization
- -Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity -
- Material Mediated Pyrogen -
- Bacterial Endotoxin Testing -
- -Subacute Toxicity
- Subchronic Toxicity -
- Genotoxicity -
- Intramuscular Implantation -
- Hemocompatibility, Hemolysis Direct Contact -
- -Hemocompatibility, Hemolysis Indirect Contact
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Hemocompatibility, Thrombogenicity In Vitro Blood Loop Assay --Hemocompatibility, Complement Activation Hemocompatibility, Mechanically Induced Hemolysis -Chronic Toxicity --Carcinogenicity Results of the functional, performance and biocompatibility testing support the determination of substantial equivalence. In accordance with FDA 21 CFR Section 807.92, and based on the indications for use, technological characteristics, and safety and performance testing, SUMMARY OF the subject Power Acute Triple Lumen Hemodialysis Catheter met the minimum requirements that are considered adequate for its intended use SUBSTANTIAL EQUIVALENCE and is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to the currently marketed predicate device.
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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.
