K241523 · Laborie Medical Technologies, Corp. · FBK · Aug 27, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K241523
Device Name
injeTAK Adjustable Tip Needle (DIS199; DIS201)
Applicant
Laborie Medical Technologies, Corp.
Product Code
FBK · Gastroenterology, Urology
Decision Date
Aug 27, 2024
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.
Device Story
The injeTAK Adjustable Tip Needle is a manual surgical instrument used during cystoscopic procedures to deliver drugs into bladder tissue. The device consists of a needle cannula, handle, needle length dial, hub/luer connector, lock-pin, and seal ring. The operator, typically a surgeon, uses a rigid or flexible cystoscope to guide the needle to the target site. The needle length dial allows the surgeon to adjust the penetration depth (0-5mm) via a lock-pin mechanism. The device is provided sterile for single use. It does not contain software or electronic components. By enabling precise, adjustable-depth injections, the device facilitates targeted drug delivery, potentially improving therapeutic outcomes for patients undergoing cystoscopic interventions.
Clinical Evidence
No clinical testing was included in this submission. Evidence is based on non-clinical bench testing, including functional performance, packaging integrity, sterilization validation, and accelerated aging studies to verify design specifications.
Technological Characteristics
Manual endoscopic injection needle. Components: needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, seal ring. Adjustable penetration depth (0-5mm). Sterile, single-use. No software, electronics, or energy source. Materials are identical to the predicate G1 version.
Indications for Use
Indicated for patients undergoing cystoscopic procedures requiring the delivery of legally marketed drugs into tissues or structures.
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 27, 2024
Laborie Medical Technologies Corp. Thomas Hirte Sr. Director Regulatory Affairs 180 International Drive Portsmouth, New Hampshire 03801
Re: K241523 Trade/Device Name: injeTAK Adjustable Tip Needle (DIS199; DIS201) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Received: August 2, 2024
Dear Thomas Hirte:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
Image /page/2/Picture/3 description: The image shows the name "Mark R. Kreitz -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and clearly legible.
for Mark J. Antonino, M.S Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology 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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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241523
Device Name
injeTAK Adjustable Tip Needle (DIS199; DIS201)
Indications for Use (Describe)
The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| | K241523 | |
|-------------------|----------------------------|-------------------------|
| 510(k) #: K241523 | 510(k) Summary Page 1 of 2 | Prepared on: 2024-08-01 |
| Contact Details | 21 CFR 807.92(a)(1) |
|-----------------------------|-----------------------------------------------------------|
| Applicant Name | Laborie Medical Technologies Corp. |
| Applicant Address | 180 International Drive Portsmouth NH 03801 United States |
| Applicant Contact Telephone | 978-277-6432 |
| Applicant Contact | Mr. Thomas Hirte |
| Applicant Contact Email | thirte@laborie.com |
| Device Name | 21 CFR 807.92(a)(2) |
|---------------------|-------------------------------------------------------|
| Device Trade Name | injeTAK Adjustable Tip Needle (DIS199; DIS201) |
| Common Name | Endoscope and accessories |
| Classification Name | Endoscopic Injection Needle, Gastroenterology-Urology |
| Regulation Number | 876.1500 |
| Product Code(s) | FBK, N/A |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|------------------------------------|---------------------|
|------------------------------------|---------------------|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K090830 | injeTAK Adjustable Tip Needle | FBK |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|----------------------------|---------------------|
|----------------------------|---------------------|
The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues
of structures during cystoscopic procedures. They are provided sterile for single use only.
The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure
lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly
depending on the skill of surgeon.
The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the
needle dependent upon the type of procedure. The intended use
does not vary based on the model number or difference in measurement specifications.
The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length
dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) |
|----------------------------------|---------------------|
|----------------------------------|---------------------|
The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures
during cystoscopic procedures. They are provided sterile for single use only.
| Indications for Use Comparison | 21 CFR 807.92(a)(5) |
|--------------------------------|---------------------|
|--------------------------------|---------------------|
The indications for use of the proposed device remain the same as the predicate device
| Technological Comparison | 21 CFR 807.92(a)(6) |
|--------------------------|---------------------|
|--------------------------|---------------------|
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#### K241523
The basic technology for the subject device and the predicate device (injeTAK Adjustable Tip Needles) is the same. The injeTAK Needle comprises of a needle cannula, contrast mark, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle. The injeTAK Needles do not include software or a dispensing device (i.e., syringe). The sheath is attached to housing and the needle cannula is attached to a needle hub. Five depths are listed on the needle handle (0, 2, 4, and 5), with each number corresponding to the needle tip length in millimeters. For example, when the needle lock-pin is set at the number 3, the maximum needle tip penetration depth is 3mm. There is at the distal end of the plastic sheath which provides a better view of injection spot.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical tests were conducted to verify that the subject device met all design specifications. The substantially equivalent to the predicate. No clinical testing was included in this submission.
#### Biocompatibility:
No additional testing is required since the standards do not affect the results of the Cytotoxicity & Pyrogenic tests, Sensitization tests or Intracutaneous Reactivity tests previously conducted on the inje TAK needles. The performed biocompatibility tests show that the injeTAK needles are safe and perform as intended. The materials of all components in the device have not changed and stay as exact the same as existing G1 needle that the device biocompatibility will be well maintained for injeTAK G2 versions (DIS 199 & DIS 201).
### Packaging:
InjeTAK Packaging Design Verification was completed on the packaging change to provide results of the product's packaging testing against released requirements to ensure the integrity of primary packaging mance at the final point of delivery after enduring the worst-case transportation conditions.
lnjeTAK Adjustable Tip Needles meet the requirements of variously corresponding international standards after the Transportation Simulation Test by functional testing, package integrity testing. All test results passed and met the acceptance criteria.
### Sterilization:
The packaging change required the sterilization process to be revalidated in order to maintain the sterilization cycle parameters specified in the original cycle parameters/design. The testing performed confirms that sterilization output requirements were met.
#### Functional & Performance Testing:
The test was intended to verify if the device critical dimensions, function/performance meet the design specifications stated in the design files. The test results passed the acceptance criteria. Overall performance and results were positive and meet the related specifications.
The packaging material and dimension have not changes and stay as version G1. The overall footprint and weight are equivalent. Therefore, it can be concluded that the device packaging performance and integrity will be maintained for injeTAK G2, and revalidation tests are not needed.
# Accelerated Aging and Shelf Life:
No additional accelerated aged tests were needed for the G2 subject device versions (DIS199 & DIS201) of the InjeTAK Needles. Since there was no change in the material, biocompatibility, packaging, aging and/or sterilization process for the G2 needles versions, the accelerated test reports conducted on the G predicate versions (DIS198 & DIS201) of the InjeTAK needles are applicable to the G2 versions as well.
The impact of aging (i.e. shelf life) on functionality and performance of the leject device versions (DIS199 & DIS201) remains unchanged. The three main functions – flow rate, needle leur leek test were evaluated. The essential functionality and performance of hjeTAK G2 version (DIS199 & DIS201) passed all requirements after accelerated aging and are therefore acceptable for the three year shelf life
Verification and Validation testing were performed on the InjeTAK Needles will perform as intended. All testing passed. Details are provided in the verification and validation section of this submission
