(27 days)
Not Found
No
The summary describes a mechanical device for deploying a pre-tied suture and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as a ligating loop for soft tissue approximation and ligation, which is a surgical tool rather than a therapeutic device designed to treat a disease or condition.
No
Explanation: The Saph-Loop™ Ligating Loop is described as a device for general soft tissue approximation and/or ligation using a pre-tied knot. Its function is to deploy a suture for ligation, which is a therapeutic or surgical action, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly outlines a physical deployment device consisting of a tube carrier, handle, and pull ring, indicating it is a hardware device, not software-only.
Based on the provided information, the Saph-Loop™ Ligating Loop is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which are surgical procedures performed on the body, not with samples taken from the body for diagnostic purposes.
- Device Description: The description details a surgical tool for deploying suture, not a device for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Saph-Loop™ is a surgical tool used during a procedure.
N/A
Intended Use / Indications for Use
The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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)
Not Found
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.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
K02410
510(k) Summary of Substantial Equivalence
1. MANUFACTURER:
Genzyme Biosurgery A division of GENZYME CORPORATION 600 Airport Road Fall River, MA 02720
Contract: Karen K. Sylvia, Sr. Regulatory Specialist Date Prepared: 22 July, 2002
2. DEVICE:
| Tradename: | Saph-Loop™ Ligating Loop |
|---|---|
| Classification: | Nonabsorbable poly(ethylene terephthalate) surgical suture |
| per 21 CFR § 878.5000. | |
| Common Name: | Suture with integral Deployment Device |
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence is the Tevdek® II suture currently marketed by Genzyme Biosurgery, Fall River, MA 02720 (K001440). This 510(k)for Tevdek® II NextStitch™ and "silkv" II POLYDK® NextStitch™ Cardiovascular Valve Suture is a special configuration of Tevdek® II.
4. DEVICE DESCRIPTION:
Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.
5. INTENDED USE:
The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
6. COMPARISON
The Saph-Loop™ Ligating Loop is a means to deploy a cut length of Tevdek® II with a pre-tied knot. The suture is the same suture as currently marketed by Genzyme Biosurgery with the addition of the carrier tubing and handle for deployment.
The determination of substantial equivalence for this device was based on a detailed device description, conformance to consensus standards and voluntary standards.
Genzyme Biosurgery, A division of GENZYME CORPORATION Fall River, MA 02720
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that suggest a profile. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
Genzyme Biosurgery Karen K. Sylvia Senior Regulatory Specialist 600 Airport Road Fall River, Massachusetts 02720
Re: K022410
Trade/Device Name: Saph-Loop™ Ligating Loop Regulation Number: 878.5000 Regulation Name: Non-absorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: July 18, 2002 Received: July 24, 2002
Dear Ms. Sylvia:
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. Drue, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
2
Page 2 - Ms. Karen K. Sylvia
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Mark A. Milkerma
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) Device Name
Saph-Loop™ Ligating Loop
Indications for Use
The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliken
(Division Sign-Off) Di ision of General, Restorative and Neurological Devices
510(k) Number K022410
Prescription Use
(Per 21 CFR § 801.109)
OR
Over-the-Counter Use _
(Optional Format 1-2-96)