(71 days)
The Smith & Nephew Suture Collet is intended for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures.
The Smith & Nephew Suture Collet is indicated for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures, and general surgery. The device is not indicated for use in contraceptive tubal ligation.
The Smith & Nephew Suture Collet System comprises three main components:
• the suture collet implant (ring and pin),
• the disposable cartridge assembly with threader, and
• the reusable delivery instrument.
The provided text describes a 510(k) summary for the "Smith & Nephew Suture Collet" device. This is a submission demonstrating substantial equivalence to a predicate device, not a study proving the device meets acceptance criteria in the sense of performance metrics against a medical condition.
Therefore, many of the requested sections about acceptance criteria, study design, expert ground truth, etc., are not applicable to this type of regulatory submission as they are focused on performance equivalence to a legally marketed device rather than clinical efficacy or diagnostic accuracy.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for a 510(k) submission is typically substantial equivalence to a legally marketed predicate device. This is primarily demonstrated by comparing design, materials, intended use, indications, and performance characteristics.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate | The Smith & Nephew Suture Collet is substantially equivalent to the Suture Lock, and silk 2-0 suture. Comparative strength testing demonstrates the equivalence of the Suture Lock to the predicate devices. |
| Similar design | Yes, similarities in design identified. |
| Similar materials | Suture Collet implant: Implant grade polyacetal. Suture Lock implant: Implant grade polyacetal. Delivery Instrument: Aluminum and Stainless Steel (both devices). |
| Similar intended use | Suture Collet: Management of Soft Tissue. Suture Lock: Management of Soft Tissue. |
| Similar indications for use | Suture Collet: Open and Endoscopic/Laparoscopic/Thoracoscopic Surgical Procedures. Suture Lock: Open and Arthroscopic Surgical Procedures. (While "Thoracoscopic" is added for the Suture Collet, the general scope is similar). |
| Similar sterilization method | Implant: Ethylene Oxide (both devices). Delivery Instrument: Steam autoclave or ethylene oxide (both devices). |
| Performance (e.g., strength) | Comparative strength testing demonstrates the equivalence of the Suture Collet to the predicate devices (Suture Lock and silk 2-0 suture). Specific numeric values for strength are not provided in this summary. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The submission mentions "Comparative strength testing," but does not provide details on the number of samples or tests performed.
- Data Provenance: Not explicitly stated. The testing would have likely been conducted by the manufacturer (Smith & Nephew, Inc.) as part of their product development and regulatory submission process. It is not described as involving external clinical data or retrospective/prospective studies on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the clinical sense (e.g., disease diagnosis) is not relevant to this type of device submission, which focuses on mechanical equivalence. The "ground truth" here is the performance of the predicate device and USP standard suture.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1 for clinical consensus) are not relevant to demonstrating substantial equivalence for a medical device through comparative strength testing.
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
Not applicable. This is a medical device for tissue fixation/ligation, not an AI-assisted diagnostic or imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established characteristics and performance of the legally marketed predicate devices (Suture Lock and 2-0 silk suture), against which the new device's properties (materials, design, intended use, indications, and strength) were compared. This is a regulatory "ground truth" for demonstrating equivalence rather than a clinical ground truth for a medical condition.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
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AUG - 6 1997
Section 7- 510k Summary of Safety and Effectiveness
| 7.1Statement | This summary of 510k safety and effectiveness information is being submitted inaccordance with the requirements of SMDA 1990 and CFR 807.92 | ||
|---|---|---|---|
| 7.2Submitter | Smith and Nephew, Inc.Endoscopy Division130 Forbes BoulevardMansfield, Ma. 02048 | ||
| 7.3CompanyContact | Amy WaltersClinical/ Regulatory Manager(508) 261-3776 | ||
| 7.4DeviceName | Proprietary Name: Smith & Nephew Suture ColletCommon Name:• Suture Retention Device,• Endoscopic Accessory,• Laparoscopic AccessoryClassification Name:• Suture Retention Device (79 KGS)• Endoscopic accessories (78 GCJ)• Laparoscopic accessories (85 HET) | ||
| 7.5PredicateLegallyMarketedDevices | • Suture Lock• Smith & Nephew and Acufex MIS Instruments | ||
| 7.6DeviceDescription | The Smith & Nephew Suture Collet System comprises three main components:• the suture collet implant (ring and pin),• the disposable cartridge assembly with threader, and• the reusable delivery instrument. | ||
| 7.7Intended Use | The Smith & Nephew Suture Collet is intended for use in the managment of softvessel ligation and/or fixation of soft tissue structures during open and endoscopicprocedures. | ||
| 7.8 DeviceIndications | The Smith & Nephew MIS Instruments are indicated for use in endoscopicprocedures, including thoracoscopic surgery and laparoscopic procedures. | ||
| 7.9SubstantialEquivalence | The Smith & Nephew Suture Collet is substantially equivalent to the Suture Lock,and silk 2-0 suture. Comparative strength testing demonstrates the equivalence ofthe Suture Lock to the predicate devices. | ||
| The table below summarizes the similarties of the two devices. The similarities in |
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design, materials, intended use, and indications for use between the Smith & Nephew Suture Collet and the predicate devices support the claim of substantial equivalence.
| Suture Collet | Suture Lock | |
|---|---|---|
| Implant: | ||
| Product Labeling | Sterile: Single Use Only | Sterile: Single Use Only |
| Materials | Implant grade polyacetal | Implant grade polyacetal |
| Indications | Open andEndoscopic/Laparoscopic/ThoracoscopicSurgical Procedures | Open and Arthroscopic SurgicalProcedures |
| Intended Use | Management of Soft Tissue | Management of Soft Tissue |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Delivery Instrument | ||
| Materials | Aluminum and Stainless Steel | Stainless Steel |
| Sterilization Method | Supplied non-sterile: must be sterilizedprior to use via steam autoclave orethylene oxide | Supplied non-sterile: must be sterilizedprior to use via steam autoclave orethylene oxide |
Applicant Gerry Walters
<> .
Date 5/23/97
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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 features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1997
1991
Ms. Amy L. Walters Clinical/Regulatory Manager Smith & Nephew, Inc., Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K971939
Trade Name: Smith & Nephew Suture Collet and Delivery Instrument Regulatory Class: II Product Code: KOG Dated: May 23, 1997 Received: May 27, 1997
Dear Ms. Walters:
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 enclosure) 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 determination assumes compliance with the current Good Manufacturing Practice requirements , 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
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Page 2 - Ms. Amy L. Walters
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.
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
Enclosure
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Device Name: Smith & Nephew Suture Collet
Indications for Use: The Smith & Nephew Suture Collet is indicated for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures, and general surgery. The device is not indicated for use in contraceptive tubal ligation.
Intended Use: The Smith & Nephew Suture Collet is intended for use in place of USP size 2-0 knotted silk suture in the management of soft vessel ligation and / or fixation of soft tissue structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use
§ 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.