(63 days)
Not Found
No
The 510(k) summary describes a synthetic absorbable suture, a physical medical device, with no mention of software, image processing, AI, or ML.
No
This device, L-25 synthetic absorbable sutures, is indicated for general soft tissue approximation and/or ligation. While used in a medical context, it is a tool for surgery, not a device that directly treats or prevents a disease or condition in a therapeutic manner (e.g., by administering drugs, stimulating tissues, or monitoring physiological processes for therapeutic intervention).
No
The device is described as "L-25 synthetic absorbable sutures" used for "general soft tissue approximation and/or ligation," which are therapeutic and surgical functions, not diagnostic.
No
The device is a synthetic absorbable suture, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation and/or ligation." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information about image processing, AI/ML, input imaging modality, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are typically relevant to devices that analyze data or samples.
IVDs are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This suture does not fit that description.
N/A
Intended Use / Indications for Use
L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Product codes
GAM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
SUMMARY OF SAFETY AND EFFECTIVENESS X.
JAN 0 8 2002
| SUBMITTER: | United States Surgical,
a division of Tyco Healthcare Group, LP
150 Glover Avenue
Norwalk, CT 06856 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Robert Zott |
| DATE PREPARED: | November 1, 2001 |
| CLASSIFICATION NAME: | Absorbable poly(glycolide/L-lactide)
surgical suture |
| COMMON NAME: | Surgical Suture |
| PROPRIETARY NAME: | To be determined |
| PREDICATE DEVICES: | K885018: Gut Suture (SurgigutTM)
K000037: BiosynTM Suture
K944110: VicrylTM Rapide Suture |
| INDICATIONS: | The device is indicated for use in general soft
tissue approximation and/or ligation, but not for
use in cardiovascular or neurological surgery,
microsurgery, or ophthalmic surgery. |
| MATERIALS: | Glycolide, Caprolactone, Tri-Methylene
Carbonate, and Lactide polymers. |
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three horizontal lines representing the snakes and a wavy line at the bottom representing the staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2002
Robert Zott Senior Associate, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
Re: K013671
Trade Name: L-25 Absorbable Surgical Suture Regulation Number: 878.4493 Regulation Name: Absorbable polyglycolide surgical suture Regulatory Class: II Product Code: GAM Dated: November 5, 2001 Received: November 6, 2001
Dear Mr. Zott:
We have reviewed your Section 510(k) premarket 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) 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 he 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 - Mr. Robert Zott
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 yours.
Neil R.P. Ogden
Celia M. Witten. Ph.D., M.D. H. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE V.
510(k) Number (if known): K013671
Device Name: L-25 Absorbable Surgical Suture (Trade name to be determined)
Indications For Use:
L-25 synthetic absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)
Nho forcmw
(Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K01367/