(76 days)
Not Found
Not Found
No
The document describes a mechanical surgical device for suture management and tissue fixation, with no mention of AI or ML technology in its description, intended use, or performance studies.
No.
The device is described as a surgical tool used for suture management and soft tissue ligation/fixation, not for treating a disease or condition in itself.
No
The provided text describes the Smith & Nephew Suture Lok as a device for use in surgical procedures (e.g., vessel ligation, tissue fixation) by securing sutures. There is no mention of it being used to diagnose a condition, disease, or provide diagnostic information. Its stated function is for treatment/surgical intervention.
No
The device description explicitly lists hardware components: the suture Lok implant (ring and pin), the disposable cartridge assembly with threader, and the reusable delivery instrument.
Based on the provided information, the Smith & Nephew Suture Lok is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical procedures like soft vessel ligation and fixation of soft tissue structures. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The device components (implant, cartridge, delivery instrument) are consistent with a surgical device used for manipulating tissues and sutures within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Smith & Nephew Suture Lok is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Suture Lok is indicated for use in open und endoscopic proc : iures, The Smith & Nephew Same Cor is moremes for cedures and general surgery. Th : including thoracoscopic surgery, contraception tubal ligation.
Intended Use:
The Smith & Nephew Suture Lok is intended for use in conjunction with USP size !! 2-0 and 3-0 Braided silk, nylon or polyester non-absorbable sunures in the managemen of and 3-0 Braided silk, hylon of poryester from asservatures during open and endose: pic procedures.
The Smith & Nephew Suture Lok 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 Lok is indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
The Smith & Nephew Suture Lok comprises three main components:
• the suture Lok 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 tissue structures, vessel ligation
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 Lok to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Suture Collet, Suture Lock, Smith & Nephew and Acufex MIS Instruments
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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 in flight, composed of three curved lines. The bird is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Mr. Sigi Caron Regulatory Manager 130 Forbes Boulevard Mansfield, MA 02048
JUL 2 7 2015
Re: K991500 Trade/Device Name: Smith & Nephew Suture Lok Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): April 28, 1999 Received (Date on orig SE ltr): April 29, 1999
Dear Mr. Caron,
This letter corrects our substantially equivalent letter of July 14, 1999.
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. 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
1
Page 2 -
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
(21 ST 11 P art 2007) produces/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510 (k) Number (if Known):
Device Name: Smith & Nephew Suture Lok
Indications For Use:
The Smith & Nephew Suture Lok is indicated for use in open und endoscopic proc : iures, The Smith & Nephew Same Cor is moremes for cedures and general surgery. Th : including thoracoscopic surgery, contraception tubal ligation.
Intended Use:
Intended Use:
The Smith & Nephew Suture Lok is intended for use in conjunction with USP size !! 2-0 and 3-0 Braided silk, nylon or polyester non-absorbable sunures in the managemen of and 3-0 Braided silk, hylon of poryester from asservatures during open and endose: pic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER FAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
or Over-The-Counter Use
Sign-Off
on of General Restorative Devi ാ : Ü(k) Number
3
Section 7- 510k Summary
| 7.1
Statement | This 510k summary 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 | Sigi Caron
Regulatory Manager
(508) 261-3773 |
| 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 Collet
• Suture Lock
• Smith & Nephew and Acufex MIS Instruments |
| 7.6
Device
Description | The Smith & Nephew Suture Lok comprises three main components:
• the suture Lok implant (ring and pin),
• the disposable cartridge assembly with threader, and
• the reusable delivery instrument. |
| 7.7
Intended Use | The Smith & Nephew Suture Lok is intended for use in the management of soft
vessel ligation and/or fixation of soft tissue structures during open and endoscopic
procedures. |
| 7.8 Device
Indications | The Smith & Nephew Lok is indicated for use in endoscopic procedures, including
thoracoscopic surgery and laparoscopic procedures. |
| 7.9
Substantial
Equivalence | The Smith & Nephew Suture Lok is substantially equivalent to the Suture Collet,
the Suture Lock, and braided silk, nylon or polyester 0, 2-0, and 3-0 suture.
Comparative strength testing demonstrates the equivalence of the Suture Lok to
the predicate devices. |
| | The table below summarizes the similarities of the two devices. The similarities in |
4
The table between banded use, and indications for use between the Smith & design, materials, intended ass, and ite reactedes support the claim of substantial equivalence. :
:
| Suture Lok | Suture Collet | |
|---|---|---|
| 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 | ||
| Indicated for | ||
| use with | 0, 2-0 and 3-0 braided silk, nylon or | |
| polyester sutures | 2-0 silk monofilament sutures | |
| Intended | ||
| Use | Management of Soft Tissue | Management of Soft Tissue |
| Sterilization | ||
| Method | Ethylene Oxide | Ethylene Oxide |
| Delivery Instrument | ||
| Materials | Aluminum and Stainless Steel | Aluminum and 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_
Date