(81 days)
Not Found
No
The summary describes a standard surgical suture and does not mention any AI/ML related terms or functionalities.
No.
Explanation: Surgical sutures are used to approximate tissue and facilitate healing, but they do not directly treat a disease or condition as a therapeutic device would. They are considered implantable medical devices.
No
This device, polyester surgical sutures, is used for tissue approximation and ligation during surgical procedures, which is a treatment and not a diagnostic function.
No
The device description clearly describes a physical surgical suture made of polyester, which is a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "use in general soft tissue approximation and/or ligation". This describes a device used within the body during a surgical procedure, not a device used to examine specimens outside the body to diagnose a condition.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off vessels. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Based on the provided information, this device is a surgical suture, which is a medical device used in surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic orthopedic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
Polyester Nonabsorbable Surgical Suture, USP size 9-0 through 9 available as undyed, dyed D & C Green No. 6 and as a co-braid of the undyed and dyed. The suture is sterile, braided and is provided in a variety of lengths, with or without pledgets, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.
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)
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV -Nonabsorbable Surgical Sutures, and the Guidance Document "Guidance for Surgical Suture 510(k)s" issued on August 10, 2000.
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
EXHIBIT A
510(k) Summary of Substantial Equivalence KO21019
Substantial Equivalence
In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule ".... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer | Genzyme Biosurgery
A Division of Genzyme Corporation
600 Airport Road
Fall River, MA 02720-4740 |
|--------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person | Mary E. Gray
Phone: (508) 677-6512
Fax: (508) 677-6663
e-mail: mgray@genzyme.com |
| Date Prepared | March 14, 2002 |
| Device Information | |
| Trade Name: | 'COTTONY' II, "silky" II POLYDEK® &
TEVDEK® II Polyester Nonabsorbable
Surgical Suture. |
| Common Name: | Polyester Nonabsorbable Surgical Sutures |
| Classification | Name: Non-Absorbable Poly(ethylene
terephthalate) Surgical Sutures |
Indications for Use
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic orthopedic and neurological procedures.
Device Description
Polyester Nonabsorbable Surgical Suture, USP size 9-0 through 9 available as undyed, dyed D & C Green No. 6 and as a co-braid of the undyed and dyed. The suture is sterile, braided and is provided in a variety of lengths, with or without pledgets, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.
1
EXHIBIT A
510(k) Summary of Substantial Equivalence Cont.
Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the currently cleared Polyester Nonabsorbable Surgical Sutures (#K930738).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV -Nonabsorbable Surgical Sutures, and the Guidance Document "Guidance for Surgical Suture 510(k)s" issued on August 10, 2000.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2002
Ms. Mary E. Gray, RAC Regulatory Affairs Specialist Genzyme Corporation 600 Airport Road Fall River, MA 02720-4740
Re: K021019
Trade/Device Name: 'COTTONY' II, "silky" II POLYDEK® & TEVDEK® Polyester Nonabsorable Surgical Suture Regulation Number: 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: March 25, 2002 Received: March 29, 2002
Dear Ms. Gray:
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. Iisting 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.
3
Page 2 -- Ms. Mary E. Gray, RAC
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" (21CFR 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 vours.
fo Mark N. Williamson
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
4
510(k) Number (if known) Device Name
'cottony' II DACRON, "silky" II POLYDEK® & TEVDEK® II Polyester Nonabsorbable Surgical Suture
Indications for Use
Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, orthopedic 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 N Milkman
ivicion Sion ivision of ( .. eral, Restorative and Neurolo; Jual Devices
510(k) Number: K021019
Prescription Use (Per 21 CFR § 801.109)
OR
Over-the-Counter Use _
(Optional Format 1-2-96)