Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Modified USS Polypropylene Suture is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
The provided text describes a 510(k) premarket notification for a medical device: the Modified USS Polypropylene Suture. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study.
Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving device performance against those criteria, or details about sample sizes, ground truth establishment, or expert involvement in such a study.
Instead, the submission focuses on demonstrating that the performance of the Modified USS Polypropylene Suture is substantially equivalent to a previously marketed predicate device (USS Polypropylene Suture, K954808, and Modified USS Polypropylene Suture, K010909). This is typically achieved through bench testing and material characterization to show that the new device has the same technological characteristics and performs similarly to the predicate.
Here's a breakdown of what can be inferred from the provided text, and what cannot:
Information that CANNOT be Extracted from the Provided Text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or performance metrics for the Modified USS Polypropylene Suture as part of a standalone study. It only states its performance is "substantially equivalent" to predicate devices.
- Sample size used for the test set and the data provenance: Not applicable to this type of submission which relies on substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study with "ground truth" is described.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What can be inferred from the text about the "study" (in the context of a 510(k)):
The "study" in this context is primarily a comparative analysis demonstrating substantial equivalence.
- Type of "Study": Comparative analysis for substantial equivalence.
- Acceptance Criteria & Reported Performance:
- Acceptance Criteria Implied: The device must demonstrate similar mechanical properties, biocompatibility, and intended use as the predicate device(s).
- Reported Performance: "The performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device."
- Ground Truth for Comparison: The established performance and safety profile of the predicate device (USSC Polypropylene Suture K954808 and Modified USS Polypropylene Suture K010909) serves as the "ground truth" for comparison.
- Training Set (Analogy): The historical data and successful clinical use of the predicate device could be considered analogous to a "training set" in that it informs the performance expectations and safety profile against which the new device is compared. The specific details of this data are not provided in the extract.
- How Ground Truth for "Training Set" was established: For the predicate device, its ground truth was established through its own 510(k) clearance based on substantial equivalence and subsequent "successful clinical applications."
Summary Table:
| Feature | Description (Based on provided text) |
|---|---|
| Acceptance Criteria | Implied: Demonstrate substantial equivalence in performance (e.g., mechanical properties, biocompatibility) and intended use to the predicate devices. |
| Reported Device Performance | "The performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device." |
| Sample Size (Test Set) | Not applicable for this type of submission. Demonstration of substantial equivalence relies on comparative testing to predicates, not a clinical trial with a "test set" to prove absolute performance against specific criteria. |
| Data Provenance (Test Set) | Not applicable. |
| Number of Experts & Qualifications (Test Set GT) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study | No. The study is a comparative one against predicate devices. |
| Type of Ground Truth Used | For comparison: The established performance and safety profile of the predicate device(s) (USSC Polypropylene Suture K954808, Modified USS Polypropylene Suture K010909) from their own regulatory clearances and "successful clinical applications." |
| Sample Size (Training Set) | Not applicable in the traditional sense. The "training data" is the historical performance and data of the predicate devices. Specific quantitative sample sizes are not provided in the text. |
| How Ground Truth for Training Set was Established | The predicate devices' ground truth was established through their prior 510(k) clearances (also based on substantial equivalence) and documented "successful clinical applications" over time, indicating their safety and effectiveness for their intended use. |
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| SUBMITTER: | United States Surgical,a division of Tyco Healthcare Group LP150 Glover AvenueNorwalk, CT 06856 |
|---|---|
| CONTACT PERSON: | Sharon L. Murphy |
| DATE PREPARED: | April 14, 2005 |
| CLASSIFICATION NAME: | Nonabsorbable Polypropylene Surgical Suture |
| COMMON NAME: | Modified USS Polypropylene Suture |
| PROPRIETARY NAME: | To be determined |
| PREDICATE DEVICES: | USSC Polypropylene Suture (K954808)Modified USS Polypropylene Suture (K010909) |
| INTENDED USE: | Modified USS polypropylene sutures are indicated foruse in general soft tissue approximation and/or ligation,including use in cardiovascular, ophthalmic, andneurological surgery. |
| MATERIALS: | Like all the devices manufactured by United StatesSurgical, a division of Tyco Healthcare Group LP, theModified USS Polypropylene Suture is composedentirely of biocompatible materials which are incompliance with ISO 10993-1 for their intended patientcontact profile. |
| PERFORMANCE: | The performance of the Modified USS PolypropyleneSuture is substantially equivalent to the currentlymarketed USS Polypropylene Suture, which has beensuccessfully used in clinical applications as a woundclosure device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem in the center, which consists of a stylized human figure with three heads in profile. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2005
Ms. Sharon L. Murphy Director, Regulatory Affairs United States Surgical, 150 Glover Avenue Norwalk, Connecticut 06856
Re: K050947
Trade/Device Name: Modified USS Polypropylene Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 3, 2005 Received: May 4, 2005
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegains and the Medical Device Amendments, or to commence prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The 1 ou may, merclore, market the Act include requirements for annual registration, listing of general controls provisions of viactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 across. Existing major regulations affecting your device it may be subject to Saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri bristian that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I cuttar statutes and regainents, 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneering your mance of your device to a legally premarket notification. "The I DTP Intering circusion 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), please If you desire specific advice for your aconcerner . Also, please note the regulation entitled, contact the Office of Compunation at (216) = 16 = 21 = 3 Part 807.97). You may obtain Milsoranuing by reference to promanton in the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use V.
K050947 510(k) Number (if known):
Device Name:
Modified USS Polypropylene Suture
Indications For Use:
Modified USS polypropylene sutures are indicated for use in general soft tissue Mounted OBS porypropyrent sincluding use in cardiovascular, ophthalmic, and neurological surgery.
-------------- OR Over-The-Counter Use:____ × Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Restorative
Surgical Devices
Ko 5094
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.