(68 days)
The device is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Polysorb* Synthetic Absorbable Suture with Modified Packaging shall remain identical to the predicate device, an absorbable poly(glycolide/L-lactide) surgical suture. with the addition to the packaging of an injection port to the inner foil pouch.
The provided document is a 510(k) summary for a medical device, specifically an absorbable surgical suture. It describes the device, its intended use, and its equivalence to a predicate device. It does not present a study that establishes acceptance criteria for new functionality or a new AI/software-driven device. Instead, it refers to "in-vitro studies" to demonstrate substantial equivalence to a predicate device for an existing product with a modified packaging.
Therefore, many of the requested categories are not applicable to the information provided in this 510(k) summary. I will fill in the applicable information and note when a section is not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. It states that "In-vitro studies were performed...to demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." This implies that the performance after pre-wetting should be comparable to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suture's functional performance remains substantially equivalent to the predicate device after pre-wetting with sterile saline (0.9% NaCl) via the injection port for up to 12 hours at room temperature prior to use. | In-vitro studies "demonstrate that the functional performance of the suture is substantially equivalent to the predicate device when pre-wetted with sterile saline (0.9% NaCl) using the injection port for up to 12 hours at room temperature prior to use." (No specific metrics or data provided in this summary). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified in the provided 510(k) summary.
- Data provenance: Not specified, but the studies were "in-vitro."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a surgical suture, and the studies were "in-vitro" to assess physical properties and performance, not diagnostic interpretations requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/software-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The equivalence was based on "functional performance" in "in-vitro studies," likely involving mechanical testing or other objective physical measurements, rather than clinical ground truth as understood in diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI/software-driven device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
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United States Surgical, a division of Tyco Healthcare Group, LP
510(K) SUMMARY: E.
JAN 2 9 2007
| Submitter: | United States Surgical,a division of Tyco Healthcare Group, LP150 Glover Avenue, Norwalk, CT 06856(203) 845-4515 |
|---|---|
| Contact Person: | Robert Zott, Program Director,Regulatory Affairs |
| Date Prepared: | January 24, 2007 |
| Device Classification Name: | Absorbable poly(glycolide/L-lactide) surgical suture |
| Device Common Name: | Surgical Suture |
| Device Proprietary Name: | Polysorb* Synthetic Absorbable Suture with ModifiedPackaging (Note: The trade name for the packaging isyet to be determined.) |
| Predicate Device(s): | K981935: Modified Polysorb* Suture (manufactured byU.S. Surgical, a division of Tyco Healthcare Group, LP) |
| Device Description: | Polysorb* Synthetic Absorbable Suture with ModifiedPackaging shall remain identical to the predicate device,an absorbable poly(glycolide/L-lactide) surgical suture.with the addition to the packaging of an injection port tothe inner foil pouch. |
| Technological Characteristics: | The injection port shall enable the injection of sterilesaline (0.9% NaCl) into the pouch for pre-wetting of thesuture under sterile conditions prior to use. |
| Performance Data: | In-vitro studies were performed in accordance with theClass II Special Controls Guidance Document: SurgicalSutures; Guidance for Industry and FDA, issued on June3, 2003 to demonstrate that the functional performanceof the suture is substantially equivalent to the predicatedevice when pre-wetted with sterile saline (0.9% NaCl)using the injection port for up to 12 hours at roomtemperature prior to use. |
| Indications: | The device is indicated for use in soft tissueapproximation or ligation and ophthalmic surgery, butnot in cardiovascular or neural tissue. |
| Materials: | Coated glycolide and lactide copolymer. |
- Polysorb is a trademark of United States Surgical,
a division of Tyco Healtchcare Group, LP
- Traditional 510(k) for Polysorb* Synthetic
Absorbable Suture with Modified Packaging 510(k) Summary Revised on January 24, 2007
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tyco Healthcare Group, LP % Mr. Robert Zott Program Director, Regulatory Affairs United States Surgical 150 Glover Avenue Norwalk, Connecticut 06856
JAN 2 9 2007
Re: K063536 Trade/Device Name: Absorbable poly(glycolide/L-lactide) Surgical suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: November 22, 2006 Received: November 22, 2006
Dear Mr. Zott:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 be 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
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Page 2 - Mr. Robert Zott
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.
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), please contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ka. N. M.
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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063536 1/1
D. STATEMENT OF INDICATIONS FOR USE:
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Polysorb* Synthetic Absorbable Suture with Modified Packaging (Note: The trade name for the packaging is yet to be determined.)
Polysorb* Synthetic Absorbable Suture with Modified Packaging is Indications For Use: indicated 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 Device Evaluation (ODE)
X Prescription Use: ____ OR Over-The-Counter Use:_________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510( Number L 06353x
- Polysorb is a trademark of United States Surgical, a division of Tyco Healtchcare Group, LP
Traditional 510(k) for Polysorb* Synthetic Absorbable Suture with Modified Packaging November 22, 2006
§ 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.