(50 days)
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No
The document describes surgical sutures and does not mention any AI or ML related terms or functionalities.
No
The device is a suture used for soft tissue approximation and ophthalmic surgery, which is a tool used in a therapeutic procedure rather than a therapeutic device itself that directly treats a condition or disease.
No
Explanation: The device described is a suture, which is used for surgical tissue approximation and not for diagnosing medical conditions.
No
The device description clearly states it is composed of "biosafe materials," indicating a physical, non-software component (sutures).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and ophthalmic surgery." This describes a surgical device used in vivo (within the body) for physical repair.
- Device Description: The description mentions the sutures are "composed of biosafe materials," which is consistent with a surgical implant or device used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the USSC* POLYSORB* CSL** sutures are a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"USSC* POLYSORB* CSL ** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"As is evident in the submitted information on function, indications and materials, USSC* POL YSORB* CSL ** sutures are substantially equivalent to the currently marketed USSC* POLYSORB* suture as summarized below:
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are . composed of biosafe materials.
- . . USSC* POLYSORB* CSL ** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue.
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are manufactured in the same facilities using similar processes and controls.
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are ● packaged in the same facilities using similar materials, processes and controls.
- USSC* POLYSORB* CSL** sutures and other products currently marketed by United States Surgical Corporation are sterilized in the same facilities using similar processes and controls."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
"general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue."
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
"K963253"
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
§ 878.4493 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
OCT -8 1996
UNITED STATES SURGICAL CORPORATION 510(K) PREMARKET NOTIFICATION USSC* POLYSORB* CSL** SUTURE
510(k) SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
As is evident in the submitted information on function, indications and materials, USSC* POL YSORB* CSL ** sutures are substantially equivalent to the currently marketed USSC* POLYSORB* suture as summarized below:
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are . composed of biosafe materials.
- . . USSC* POLYSORB* CSL ** sutures and the existing USSC* POLYSORB* sutures are indicated for use in general soft tissue approximation and ophthalmic surgery but not use in cardiovascular or neural tissue.
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are � manufactured in the same facilities using similar processes and controls.
- USSC* POLYSORB* CSL** sutures and the existing USSC* POLYSORB* sutures are ● packaged in the same facilities using similar materials, processes and controls.
- USSC* POLYSORB* CSL** sutures and other products currently marketed by United States Surgical Corporation are sterilized in the same facilities using similar processes and controls.
*Trademark of United states Surgical Corporation ** Trademark name not yet determined