(56 days)
No
The document describes a surgical suture and its material composition. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties like tensile strength and diameter, not algorithmic performance.
Yes
Explanation: The device is a suture used for soft tissue approximation or ligation and ophthalmic surgery, which are therapeutic interventions.
No
Justification: The device is a surgical suture used for approximating or ligating soft tissue and in ophthalmic surgery. It is a therapy device, not a diagnostic device as it does not gather or analyze data to identify a condition or disease.
No
The device description clearly states it is a physical suture made of copolymer material, 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 opthalmic surgery." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "suture," which is a material used to stitch tissues together. This is a physical implant/device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Modified USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and opthalmic surgery, but not in cardiovascular or neural tissue.
Product codes
Not Found
Device Description
Modified USSC* POLYSORB* sutures are composed of LACTOMER* 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, opthalmic (but not cardiovascular or 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
Meets the requirements of U.S.P. Synthetic Absorbable Suture Monograph for tensile strength, needle attachment and diameter.
Key Metrics
Not Found
Predicate Device(s)
USSC* Braided Synthetic Absorbable Suture** (K961997), USSC* POLYSORB* Sutures (K963253)
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
UNITED STATES SURGICAL CORPORATION 510(k) PREMARKET NOTIFICATION Modified USSC* POLYSORB* Suture**
MAY - 5 1997
510(K) SUMMARY OF INFORMATION SUPPORTING SUMMARY SAFETY AND EFFECTIVENESS
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
(203) 845-1000 |
------------ | ------------------------------------------------------------------------------------------------ |
---|
CONTACT PERSON: Jonathan Gilbert
March 6, 1997 DATE PREPARED:
CLASSIFICATION NAME: Absorbable Surgical Suture
Synthetic Absorbable Surgical Suture COMMON NAME:
PROPRIETARY NAME: The trademark name of this device has not yet been determined.
USSC* Braided Synthetic Absorbable Suture** (K961997) PREDICATE DEVICE: and USSC* POLYSORB* Sutures (K963253)
Modified USSC* POLYSORB* sutures are composed of DEVICE DESCRIPTION: LACTOMER* 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 USSC* POLYSORB* Sutures are indicated for use in soft tissue approximation or ligation and opthalmic surgery, but not in cardiovascular or neural tissue.
Modified USSC* POLYSORB* sutures are composed of MATERIALS LACTOMER* glycolide/lactide copolymer which is a synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic acids).
Meets the requirements of U.S.P. Synthetic Absorbable PERFORMANCE: Suture Monograph for tensile strength, needle attachment and diameter.
*Trademark of United states Surgical Corporation ** Trademark name not yet determined