(329 days)
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
The provided text describes the submission of a 510(k) premarket notification for a new surgical suture device named PREMIO®. The purpose of this submission is to demonstrate that PREMIO® is substantially equivalent to a legally marketed predicate device, PRONOVA™. The document focuses on comparing the new device to the predicate device, particularly regarding their technological characteristics and intended use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to USP Monographs for non-absorbable surgical sutures | "Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs..." |
| Conformance to EP Monographs for non-absorbable surgical sutures | "...and with the EP Monographs for non-absorbable surgical sutures." |
| Biocompatibility of raw materials | "The raw material used for both medical devices [PREMIO® and PRONOVA™] is commonly used in surgical applications and has been proven to be biocompatible." |
| Intended Use | "PREMIO® has the same intended use as the predicate device PRONOVA™: general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery." |
| Technological Characteristics | "Our new device PREMIO® has similar technological characteristics as the predicate device PRONOVA™. Like currently marketed PRONOVA™ suture, PREMIO® is a sterile monofilament synthetic non-absorbable surgical suture..." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that non-clinical laboratory testing was performed. However, it does not specify the sample size used for this testing. The data provenance is also not detailed beyond mentioning "non-clinical laboratory testing." It does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be based on laboratory testing against established pharmacopoeia standards (USP and EP) rather than expert review of cases or outcomes.
4. Adjudication Method for the Test Set
Since there is no mention of experts or a test set requiring adjudication in the context of human review, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. The submission focuses on demonstrating substantial equivalence through technological and performance comparisons against established standards and a predicate device, not on assessing human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device being described. PREMIO® is a physical surgical suture, not a software algorithm or AI-powered system designed for standalone performance or human-in-the-loop assistance.
7. Type of Ground Truth Used
The ground truth used for evaluating PREMIO® appears to be the established standards and specifications outlined in the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for non-absorbable surgical sutures. The biocompatibility of the raw material is also cited as "proven," likely referring to existing literature or prior regulatory approvals for the material.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this submission. PREMIO® is a physical medical device, not a machine learning model that requires a training set. The evaluation is based on laboratory testing and comparison to a predicate device and monograph standards.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Péters Surgical. The logo features a stylized ear graphic on the left, followed by the name "Péters" in a cursive font. Below "Péters", the word "SURGICAL" is printed in a smaller, sans-serif font. The overall design is simple and professional, likely representing a company specializing in surgical products or services related to the ear.
JAN 17 2007 SECTION 11
510(k) SUMMARY [As Required by 21 CFR 807.92(c)]
Information supporting claims of substantial equivalence, as defined under the Federal Food, drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
510(k) Summary Date prepared
November 6, 2006
510(k) Submitter
PETERS SURGICAL Z.I. Les vignes 42 rue Benoît Frachon Bobigny, FRANCE 93013
Registration Number: 3004060107 Owner/Operator Number: 9009304 Phone: 33-148-106262 Fax: 33-148-912299
Official Correspondent
Hinda BENKIRANE Regulatory Affairs Manager PETERS SURGICAL Bobigny, FRANCE, 93013 Phone: 33-148-106254
New Device Name
Trade name: Common/Usual name: Classification name:
PREMIO® Polyvinylidene fluorure Synthetic Nonabsorbable Suture Suture, Nonabsorbable, Synthetic, Polypropylene
New Device Classification
Class II in 21 CFR $878.5010 by the General and Plastic Surgery Devices Panel, Nonabsorbable Polypropylene Surgical Suture (GAW).
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Image /page/1/Picture/0 description: The image shows the logo for Peters Surgical. The logo features a stylized ear on the left, followed by the name "Péters" in a cursive font. Below "Péters", the word "SURGICAL" is written in smaller, block letters. The ear graphic is black and white, and the text is also in black.
Predicate Device Name
PRONOVATM, Nonabsorbable Surgical Suture (K001625).
Statement of intended use
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular and vascular surgery, in ophthalmic surgery and in neurological surgery.
PREMIO® has the same intended use as the predicate device PRONOVATM
New Device Description
PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
Summary of Technological Characteristics of New Device compared to Predicate Device
Our new device PREMIO® has similar technological characteristics as the predicate device PRONOVA™. Like currently marketed PRONOVA™ suture, PREMIO® is a sterile monofilament synthetic non-absorbable surgical suture that conforms to the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. The raw material used for both medical devices is commonly used in surgical applications and has been proven to be biocompatible.
Performance data
Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for non-absorbable surgical sutures.
Conclusions
Based on the 510(k) summary (21 CFR 807) and the information provided herein, we conclude that our New Medical Device PREMIO® is substantially equivalent to the Predicate Device PRONOVA™ under the Federal Food, Drug, and Cosmations
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Peters Surgical % Ms. Annie Lasserre Z.I. Les vignes 42 Rue Benoît FRACHON Bobigny, FRANCE 93013
JAN 17 2007
Re: K060465
Trade/Device Name: PREMIO® Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: MXW Dated: November 6, 2006 Received: November 24, 2006
Dear Ms. Lasserre:
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 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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Page 2 - Ms. Annie Lasserre
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) 276-0115. 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,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows the logo for Peters Surgical. The logo consists of a stylized black shape resembling an ear on the left, followed by the name "Péters" in a handwritten-style font. Below "Péters" is the word "SURGICAL" in smaller, block letters. The overall design is simple and professional, likely representing a company specializing in surgical products or services related to the ear.
SECTION 10
STATEMENT OF INDICATIONS FOR USE
K060465 510(k) Number
Device Name PREMIO®
Indications for use
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
PREMIO/Traditional 510(K)/February 2006
§ 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.