(27 days)
No
The document describes a mechanical surgical device for suture ligation and fixation and does not mention any AI or ML components or functionalities.
No.
The device is described as being used for "soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures" using non-absorbable sutures, which indicates a surgical tool rather than a therapeutic device that treats a disease or condition. Its function is to facilitate the surgical procedure, not to provide therapy itself.
No
Explanation: The "Intended Use / Indications for Use" section indicates that the device is for "soft vessel ligation and/or fixation of soft tissue structures" during surgical procedures. This describes a therapeutic or surgical function, not a diagnostic one.
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". This indicates it is a physical medical device, not software-only.
Based on the provided information, the Smith & Nephew SutureLok is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for ligating vessels and fixing soft tissue structures during open and endoscopic procedures. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The components (implant, cartridge, delivery instrument) are consistent with a surgical device used for mechanical manipulation of tissue.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance study mentioned focuses on comparative strength testing, which is relevant to the mechanical function of a surgical device, not the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The SutureLok does not fit this description.
N/A
Intended Use / Indications for Use
The Smith & Nephew SutureLok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation. The Smith & Nephew SutureLok is intended for use in conjunction with USP size 0, 2-0 and 3-0 braided silk, nylon or polyester non-absorbable sutures in the management of soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures.
Product codes
OCW, KGS, GCT, HET
Device Description
The Smith & Nephew SutureLok 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 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 demonstrated the equivalence of the SutureLok to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the heading of a document or letter. The font is a sans-serif typeface, and the overall impression is one of official government correspondence.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Endoseopy Division Mr. Nicholas Condakes Regulatory Affairs Specialist 160 Dascomb Road Andover. MA 01810
JUL 2 7 2015
K000717 Re: Trade/Device Name: SutureLok Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): February 29, 2000 Received (Date on orig SE ltr): March 3, 2000
Dear Mr. Condakes,
This letter corrects our substantially equivalent letter of March 30, 2000.
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
http://www.fda.gov/MedicalDevices/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
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Smith & Nephew SutureLok |
| Indications for Use | The Smith & Nephew SutureLok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation. |
| Intended Use | The Smith & Nephew SutureLok is intended for use in conjunction with USP size 0, 2-0 and 3-0 braided silk, nylon or polyester non-absorbable sutures in the management of soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures. |
(Division Sign-Off)
Division of General Restorative Devices K000717
510(k) Number
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
・・・
kqq4717
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KQQW17
Section V
MAR 3 0 2000
510(k) Summary Special 510(k): Date Prepared: February 29, 2000
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
A. Submitter Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Road Andover, Massachusetts 01810
- B. Company Contact
Nicholas Condakes Regulatory Affairs Specialist
C. Device Name
Trade Name: Smith & Nephew SutureLok Common Name:
- Suture Retention Device
- Endoscope Accessory
- Laparoscope Accessory ●
Classification Name:
- Suture Retention Device (KGS)
- Endoscope Accessory (GCT)
- . Laparoscope Accessory (HET)
D. Predicate Devices
The Smith & Nephew SutureLok is substantially equivalent in design, materials, function and intended use to the following devices in commercial distribution:
Smith & Nephew SutureLok-K991500
E. Description of Device
The Smith & Nephew SutureLok comprises three main components:
- The suture Lok implant (ring and pin) .
- The disposable cartridge assembly with threader, and ●
- The reusable delivery instrument
F. Indications for Use
The Smith & Nephew SutureLok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation.
4
Intended Use G.
Kooon17
The Smith & Nephew SutureLok is intended for use in conjunction with USP size 0, 2-0 and 3-0 braided silk, I ne onlyester non-absorbable sutures in the management of soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures.
H. Comparison of Technological Characteristics
The Smith & Nephew SutureLok is identical to the predicate device in its intended use, and similar in safety and effectiveness. The only difference between the new implant and the predicate device is that the Lock Ring outside diameter is redesigned to add a titanium sleeve and to increase distal end material thickness.
Comparative strength testing demonstrated the equivalence of the SutureLok to the predicate device.
Nicholas Cordukes
Nicholas Condakes Regulatory Affairs Specialist