(30 days)
The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
The Contour Midface Opposing Uni-Directional Threads are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture material. The 45 centimeter length incorporates a Uni-directional-barbed design with center of the thread being smooth for a distance of a nominal two inches. The Threads will be supplied with 7 inch needles attached to both ends. The needles are made of 400 series stainless steel. The threads are supplied sterile for single use.
The provided text is a 510(k) summary for a medical device called "The Contour Midface Opposing Uni-Directional Threads." This type of document focuses on establishing substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria, specific study design, and performance metrics is not available in this document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided 510(k) summary in the format of a table with specific pass/fail criteria and performance results. 510(k)s often rely on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than meeting predefined, quantifiable acceptance criteria for novel performance.
However, the document mentions "Physical testing was conducted on the thread to USP 27 for tensile strength." This implies that the device met the tensile strength requirements specified in USP 27 for its material (polypropylene suture). Without access to USP 27, the specific criteria and the exact reported performance cannot be detailed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Bench and animal evaluations have demonstrated the device to be safe and effective." However, it does not provide details about the sample sizes used for these evaluations.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This device is a surgical suture. Its "ground truth" performance would typically be assessed through physical material testing (e.g., tensile strength), biocompatibility evaluations, and potentially animal studies for safety and effectiveness in a biological context, rather than expert interpretation of data like in an AI/diagnostic device study. The document does not mention any expert consensus in this regard.
4. Adjudication method for the test set
Not applicable/Not specified. See explanation above.
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 document describes a surgical suture, not an AI or diagnostic device designed for human reader interpretation. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (suture), not an algorithm.
7. The type of ground truth used
The implicit "ground truth" for this device would be established through:
- Material Specifications: Adherence to USP (United States Pharmacopeia) standards for polypropylene sutures, specifically for tensile strength ("Physical testing was conducted on the thread to USP 27 for tensile strength.").
- Biocompatibility: Demonstrated through "Bench and animal evaluations."
- Performance in vivo: Demonstrated through "animal evaluations" for safety and effectiveness.
- Substantial Equivalence: The primary "truth" demonstrated in a 510(k) is that the device is as safe and effective as a legally marketed predicate device.
8. The sample size for the training set
Not applicable/Not specified. This is not an AI/ML device that requires a training set. If "training set" refers to data used to inform the design or initial development, the document doesn't provide such details.
9. How the ground truth for the training set was established
Not applicable/Not specified. See explanation above.
Summary of Device and Performance Information Found:
- Device Name: The Contour Midface Opposing Uni-Directional Threads
- Intended Use: For use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
- Material: Clear, nonabsorbable, sterile, surgical strand of USP size 2-0 polypropylene suture material.
- Technological Characteristics: Polypropylene material is commonly used in medical applications and proven biocompatible. Has "Uni-directional-barbed design with center of the thread being smooth for a distance of a nominal two inches."
- Performance Data Mentioned: "Physical testing was conducted on the thread to USP 27 for tensile strength." "Bench and animal evaluations have demonstrated the device to be safe and effective."
- Substantial Equivalence Claimed to: Contour Extended Length Threads (K041593) for intended use. States "The Contour Midface Opposing Uni-Directional Thread uses the same suture material shown to have tensile strength and biocompatibility suitable for this application."
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Ko 50 548 1/2
APR -- 1 2005
Image /page/0/Picture/2 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the company name in a stylized font. A black triangle is to the right of the company name.
510 (k) SUMMARY OF SAFETY AND EFFEC SUBSTANTIAL EQUIVALENCY
| Submitter: | Surgical Specialties Corporation |
|---|---|
| Address: | 100 Dennis DriveReading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth LazaroRegulatory Affairs Specialist |
| Date Prepared: | February 28, 2005 |
| Name of Device: | Contour Midface OpposingUni-directional Threads |
| Common / UsualClassification Name: | GAWSuture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Contour Extended Length Threads K041593 |
| Indications For Use: | The Contour Midface Opposing Uni-directionalThread is indicated for use in midface suspensionsurgery to fixate the cheek subdermis in an elevatedposition. |
Contour Midface Opposing Uni-Directional Threads Surgical Specialties Corporation
Image /page/0/Picture/6 description: The image shows the logo for LOOK. The logo consists of the word "LOOK" in a sans-serif font, with a stylized eye symbol replacing the second "O". Below the logo is the tagline "Precisely what you need" in a smaller font. The logo is simple and modern, and the tagline suggests that LOOK provides products or services that are tailored to the specific needs of its customers.
100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 • 800 523-3332 • Fax: 610 404-4010 ww.surgicalspecialties.com
Image /page/0/Picture/8 description: The image shows the logo for Sharpoint, a company that provides surgical tools. The logo features the company name in a stylized font, with the tagline "The Surgeon's Edge" underneath. To the right of the company name is a black triangle pointing to the right. Above the company name is a small graphic that looks like the number 8.
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Image /page/1/Picture/0 description: The image shows a logo for Surgical Specialties Corporation. The logo features the words "Surgical Specialties" in a stylized font, with the word "Corporation" written in smaller letters below. To the right of the words is a black triangle pointing to the right. Below the word "Corporation" is the phrase "Incision & Healing Technologies".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Device Description | The Contour Midface Opposing Uni-Directional Threadsare a clear, nonabsorbable, sterile, surgical strand ofpolypropylene. The base product is USP size 2-0polypropylene suture material. The 45centimeter lengthincorporates a Uni-directional-barbed design with centerof the thread being smooth for a distance of a nominaltwo inches. The Threads will be supplied with 7 inchneedles attached to both ends. The needles are made of400 series stainless steel. The threads are supplied sterilefor single use. |
|---|---|
| Technological Characteristics: | The Polypropylene material used for the MidfaceContour Threads is commonly used in medicalapplications and have been proven to bebiocompatible. Bench and animal evaluations havedemonstrated the device to be safe and effective. Itis equivalent to other 510 (k) approved surgicalsutures and identical to Surgical Specialties'Polypropylene Surgical Sutures, PMA 870064. |
| Performance Data: | Physical testing was conducted on the thread toUSP 27 for tensile strength. |
| Substantial Equivalence | The Contour Midface Opposing Uni-DirectionalThread is identical in the intended use to thepredicate The Contour Extended Length Threads.The Contour Midface Opposing Uni-DirectionalThread uses the same suture material shown to havetensile strength and biocompatibility suitable forthis application. The approved suture material isPolypropylene. The Contour Midface OpposingUni-Directional Threads intended use is in midfacesuspension surgery to fixate the cheek subdermis inan elevated position. |
The Contour Midface Uni-Directional Threads Surgical Specialties Corporation
Image /page/1/Picture/4 description: The image shows the word "LOOK" in bold, sans-serif font, followed by a small circle and a stylized image of a camera lens. Below the word "LOOK" is the phrase "Precisely what you need" in a smaller, lighter font. The logo appears to be for a company named "LOOK" that specializes in providing precise solutions.
100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 • 800 523-3332 • Fax: 610 404-4010 www.surgicalspecialties.com
Image /page/1/Picture/6 description: The image shows the logo for Sharpoint, a company that specializes in surgical tools. The logo features the company name in a stylized font, with the tagline "The Surgeon's Edge" underneath. To the right of the company name is a black triangle pointing to the left. Above the company name is a stylized image of a surgical tool.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The symbol is composed of three curved lines that create the impression of movement and dynamism.
Public Health Service
APR - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K050548
K050548
Trade/Device Name: The Contour Midface Opposing Uni-Directional Threads™
Trade/Device Name: The Contour 2012 Regulation Number: 21 CFR 878.5010 Regulation Name: Non-absorbable synthetic polypropylene suture Regulatory Class: II Product Code: GAW Dated: March 1, 2005 Received: March 2, 2005
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(ts) prematically equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regally mancedes in one include be vice Ameral Food. Drug commerce prior to May 28, 1970, the charters with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with expressed application (PMA) devices that have been reculted in accordance whiles approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approval organizions of and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls, provisions o You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include required misbranding and general controls provisions of the Act mender requirements.
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 ( If your device is classified (Sec above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation UDA may be subject to such additional controlis: Extisting major of SP8. In addition. I'DA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peach. Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a substants with other requirements of the Act
that FDA has made a determination that your device complies with onenaios. You musi that FDA has made a decemmanon that your accred by other Federal agencies. You must relievelies and list or any Federal statutes and regulations administered of exist of the station and listing (21 comply with all the Act s requirements, moradice requires practice requirements as se
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the illustry) CFR Part 807); labeling (21 CFR Part 801); god and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR Party, 21 CFR 1000 (1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 - Ms. Elizabeth Lazaro
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally premaired 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 If you demic specific as not any 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 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Erica b
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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Lososyf
Indications for Use
510(k) Number (if known):
Device Name: The Contour Midface Opposing Uni-Directional Threads™
Indications For Use:
- The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
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)
rive
§ 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.