(71 days)
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches
The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is a single patient use reloadable instrument that is intended for the use in minimally invasive surgical applications where soft tissue is being approximate with interrupted stitches. It is designed for use with a 5 mm trocar. The instrument is design for eight-knot deployments.
This document describes the 510(k) Summary of Safety and Effectiveness for the Ethicon Endo-Surgery, Inc. ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL®. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report of device performance against those criteria.
Therefore, much of the requested information regarding detailed acceptance criteria, specific reported device performance metrics (e.g., in a table), sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.
The document primarily states that "Pre-clinical laboratory evaluations were performed to ensure that the device performs as intended." and "The bench data and the animal studies demonstrated that the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® facilitated laparoscopic suturing, allowed one-handed knot deployment, and provided a secured knot in soft tissue with interrupted stitches." This is a high-level summary of performance, not detailed acceptance criteria and results.
Based on the provided text, here is what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended | Facilitated laparoscopic suturing |
| Allowed one-handed knot deployment | |
| Provided a secured knot in soft tissue with interrupted stitches |
Note: The document does not provide specific quantitative acceptance criteria (e.g., minimum knot tensile strength, duration of one-handed deployment, success rate of knot deployment) nor does it provide specific quantitative results against such criteria. The reported performance is qualitative.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document mentions "bench data and the animal studies" but does not give sample sizes for either.
- Data Provenance: Not specified. It's likely from Ethicon's internal labs (Cincinnati, Ohio, USA) but not explicitly stated. The studies are pre-clinical.
- Retrospective or Prospective: These were "pre-clinical laboratory evaluations" and "animal studies," which are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Note: For a surgical tool, "ground truth" might refer to expert assessment of the quality of the suturing/knotting or physiological outcomes in animal models, but the document does not elaborate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this is a surgical device, not an AI/imaging diagnostic device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable/not described. This is a manual surgical instrument where human interaction is integral.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Implied to be based on observations during "bench data and animal studies" to assess "facilitated laparoscopic suturing," "one-handed knot deployment," and "secured knot in soft tissue." This would likely involve direct observation and potentially measurement of knot parameters (e.g., tensile strength testing in bench studies, possibly histological evaluation or healing outcomes in animal studies), but the exact "type of ground truth" (e.g., a specific measurement or a panel of surgical experts' consensus) is not detailed.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not specified. The device is a mechanical surgical instrument, not an algorithm that requires a "training set" in the machine learning sense. The "training" here would be iterative design and testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. See point 8.
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992612
510(k) Summary of Safety and Effectiveness
| Submitter | Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
|---|---|
| Contact | Edwin O. Billips |
| Date | August 2, 1999 |
| Device Name | The Classification Name of this device is Manual Surgical Instrument; theCommon Name is Knot Tying Instrument; and the Trade/Proprietary Nameis ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with CoatedVICRYL®. |
| Predicate Device | Ethicon Endo-Surgery's ENDOPATH® Endoscopic Tissue Fastening System(ETFS)-K980022; Ethicon Endo-Surgery's ENDOPATH® Endoscopic TissueFastening System (ETFS)-K972679. |
| DeviceDescription | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with CoatedVICRYL® is a single patient use reloadable instrument that is intended for theuse in minimally invasive surgical applications where soft tissue is beingapproximate with interrupted stitches. It is designed for use with a 5 mmtrocar. The instrument is design for eight-knot deployments. |
| Intended use | The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with CoatedVICRYL® is intended for use in minimally invasive surgical applicationswhere soft tissue is being approximate with interrupted stitches. |
| Continued on next page |
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510(k) Summary of Safety and Effectiveness,
| Technologicalcharacteristics | The technological characteristics of the New Device are the same as those ofthe Predicate Devices. The ENDOPATH® Endoscopic Tissue FasteningSystem (ETFS) with Coated VICRYL® utilizes an absorbable suture toapproximate soft tissue with interrupted stitches. | ||||
|---|---|---|---|---|---|
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that the deviceperforms as intended. The bench data and the animal studies demonstratedthat the ENDOPATH® Endoscopic Tissue Fastening System (ETFS) withCoated VICRYL® facilitated laparoscopic suturing, allowed one-handed knotdeployment, and provided a secured knot in soft tissue with interruptedstitches. | ||||
| Conclusion | Based on (21 CFR §807) and the information provided herein, we concludethat the New Device is as safe, as effective, and performs as well as thelegally marketed device. |
Ethicon Endo-Surgery, Inc. ENDOPATH®ETFS with Coated VICRYL®
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes. The bird faces left, and the overall design is simple and monochromatic.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Mr. Edwin O. Billips, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
Re: K992612
Trade Name: Endopath Endoscopic Tissue Fastening System with coated VICRYL® Regulatory Class: II Product Code: GCJ
Dated: August 2, 1999 Received: August 4, 1999
Dear Mr. Billips:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent dctcrmination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Mr. Edwin O. Billips RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number (if known):_K992612
ENDOPATH Endoscopic Tissue Fastening System (ETFS) with Coa Device Name: VICRYL ・. ···
Indications For Use:
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The ENDOPATH® Endoscopic Tissue Fastening System (ETFS) with Coated VICRYL® is intended for use in minimally invasive surgical applications where soft tissue is being approximated with interrupted stitches
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAG NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K992612 |
| 510(k) Number |
Prescription Use X
(Per 21 CFR 801.109)
OR Over-The-Counter Use
(Optional Format 1
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.