(71 days)
No
The document describes a mechanical surgical device for suture management and does not mention any software, algorithms, or AI/ML components.
No.
The device is used for soft tissue ligation and fixation during surgical procedures, not for treating a disease or condition.
No
Explanation: The device is intended for "soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures," which describes a therapeutic or surgical function, not a diagnostic one. There is no mention of identifying or diagnosing medical conditions.
No
The device description explicitly lists hardware components: "the suture collet implant (ring and pin), the disposable cartridge assembly with threader, and the reusable delivery instrument."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed (implant, cartridge, delivery instrument) are all designed for surgical intervention, not for testing samples outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on physical manipulation and fixation of tissues during surgery.
N/A
Intended Use / Indications for 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.
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.
Product codes
KOG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft vessel, soft tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative strength testing demonstrates the equivalence of the Suture Lock to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG - 6 1997
Section 7- 510k Summary of Safety and Effectiveness
| 7.1
Statement | This summary of 510k safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and CFR 807.92 | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| 7.2
Submitter | Smith and Nephew, Inc.
Endoscopy Division
130 Forbes Boulevard
Mansfield, Ma. 02048 | | |
| 7.3
Company
Contact | Amy Walters
Clinical/ Regulatory Manager
(508) 261-3776 | | |
| 7.4
Device
Name | Proprietary Name: Smith & Nephew Suture Collet
Common Name:
• Suture Retention Device,
• Endoscopic Accessory,
• Laparoscopic Accessory
Classification Name:
• Suture Retention Device (79 KGS)
• Endoscopic accessories (78 GCJ)
• Laparoscopic accessories (85 HET) | | |
| 7.5
Predicate
Legally
Marketed
Devices | • Suture Lock
• Smith & Nephew and Acufex MIS Instruments | | |
| 7.6
Device
Description | 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. | | |
| 7.7
Intended Use | The Smith & Nephew Suture Collet is intended for use in the managment of soft
vessel ligation and/or fixation of soft tissue structures during open and endoscopic
procedures. | | |
| 7.8 Device
Indications | The Smith & Nephew MIS Instruments are indicated for use in endoscopic
procedures, including thoracoscopic surgery and laparoscopic procedures. | | |
| 7.9
Substantial
Equivalence | 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. | | |
| | The table below summarizes the similarties of the two devices. The similarities in | | |
047
l
1
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 and | |
| Endoscopic/Laparoscopic/Thoracoscopic | ||
| Surgical Procedures | Open and Arthroscopic Surgical | |
| Procedures | ||
| 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 sterilized | |
| prior to use via steam autoclave or | ||
| ethylene oxide | Supplied non-sterile: must be sterilized | |
| prior to use via steam autoclave or | ||
| ethylene oxide |
Applicant Gerry Walters
<> .
Date 5/23/97
2
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
3
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
4
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