(23 days)
No
The summary describes a surgical suture made of a specific copolymer and coating, with no mention of AI or ML technology in its composition, function, or intended use.
No.
The device is a suture used for approximating or ligating soft tissue, which is a structural or supportive function rather than a therapeutic one (i.e., treating or curing a disease/condition).
No
The device, Modified Polysorb* Suture, is used for soft tissue approximation or ligation and ophthalmic surgery. Its function is to hold tissue together, which is a therapeutic intervention, not a diagnostic one. Diagnostic devices are used to identify or detect a disease, condition, or state.
No
The device description clearly states it is a suture composed of a copolymer and coating, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation or ligation and ophthalmic surgery." This describes a surgical device used in vivo (within the body) for physical manipulation of tissues.
- Device Description: The description details the composition of a surgical suture, which is a physical implant/material used during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or analytical methods.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This suture does not fit that description.
N/A
Intended Use / Indications for Use
Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
The Modified Polysorb Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product codes
GAM
Device Description
Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ophthalmic, cardiovascular, neural 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)
Polysorb* Suture (K970863)
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
JUN 25 ાજુકા 510(k)_Summary of Safety and Effectiveness
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Jamie Yieh |
| DATE PREPARED: | June 1, 1998 |
| CLASSIFICATION NAME: | Absorbable Surgical Suture |
| COMMON NAME: | Synthetic Absorbable Surgical Suture |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | Polysorb* Suture (K970863) |
| DEVICE DESCRIPTION: | Modified Polysorb* Suture is composed of a glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids). The suture is coated with a mixture of caprolactone/glycolide copolymer and calcium stearoyl lactylate. |
| INTENDED USE: | Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. |
| MATERIALS: | All component materials of the Modified Polysorb* Suture are comprised of materials which are in accordance with ISO Standard # 10993-1. |
510(k) Premarket Notification June 1, 1998
:
RA05
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with its wings forming a human profile, symbolizing the department's focus on health and human well-being. The text is in all caps and the eagle is in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1998
Mr. Jamie Yieh Associate. Regulatory Affairs United States Surgical Corporation 150 Glover Avenue Norwalk. Connecticut 06856
Re: K981935 Trade Name: Modified Polysorb Suture Regulatory Class: II Product Code: GAM Dated: June 1, 1998 Received: June 2, 1998
Dear Mr. Yieh:
We have reviewed your Section 510(k) 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 that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- The Modified Polysorb Surgical Suture is indicated for use in general soft tissue 1. approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
-
- This device may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or L-lactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Modifies Polysorbsurgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
2
Page Two - Mr. Jamie Yieh
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Modified Polysorb* Suture
1V. Indications For Use:
510(k) Number (if known): K981935
Name: Modified Polysorb* Suture
Indications For Use:
Modified Polysorb* Suture has indications for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR §801.109)
Jo C. DeLeon
· Trademark name not yet determined
KVOR