(30 days)
The Contour Necklift Thread™ is indicated for use in Necklift Surgery. The Necklift Contour Threads are specifically indicated for use to fixate and elevate the subdermis to the deep fascia of the retromastoid area.
The Contour Necklift Threads™ are a clear, non-absorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture. The 25 centimeter length thread incorporates a unidirectional barbed section 10 centimeters long from the distal end. The Threads will have a 7 inch straight needle attached to the distal end and a 26 mm curved needle attached to the proximal end. The threads are supplied sterile for single use.
This 510(k) summary describes a medical device, the Contour Necklift Threads™, and asserts its substantial equivalence to existing predicate devices. However, it does not contain a traditional "study" in the sense of a clinical trial or a performance study with defined acceptance criteria and reported results.
Instead, the submission relies on the following to demonstrate safety and effectiveness:
Acceptance Criteria and Reported Device Performance
The document describes performance testing rather than specific, quantified acceptance criteria and reported numerical results in a table format.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength (USP 27 standards) | Physical testing was conducted to USP 27 tensile strength. (No specific numerical results provided) |
| Force Required to Remove After Implantation | Testing was conducted for force required to remove after implantation. (No specific numerical results provided) |
| Biocompatibility for Permanent Implantation (ISO 10993) | Biocompatibility testing was conducted per ISO 10993. (No specific numerical results provided) |
| Material/Composition Equivalence | "There is no change in chemistry, material or composition" compared to predicate devices. |
| Safety and Effectiveness Equivalence in Use | "Bench and animal evaluations have demonstrated the device to be safe and effective." |
| Substantial Equivalence for Intended Use | "The Contour Necklift Thread™ is equivalent in the intended use to the predicate devices... The use in different anatomical sites... does not change the safety and effectiveness." |
| Equivalence to Gold Standard Surgical Procedure | The device is equivalent to "PROLENE suture for what has been established as a safe and effective Gold Standard Surgical Procedure for Necklift in the last 2 decades." |
Study Details (or lack thereof)
Since a traditional study with a test set, experts, and statistical analysis is not described, the following information is not present in the document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as detailed performance study data is not provided. The document mentions "bench and animal evaluations" but no specifics on sample sizes, design, or results are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a surgical thread, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the "bench and animal evaluations," the ground truth would likely be direct measurements (e.g., tensile strength, force to remove) and histological assessment for biocompatibility. For the claim of equivalence to "Gold Standard Surgical Procedure," the ground truth is established clinical practice and historical outcomes data for Prolene™ sutures in necklifts.
- The sample size for the training set: Not applicable, as there's no machine learning algorithm involved.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Substantiation Approach:
The submission for the Contour Necklift Threads™ relies primarily on demonstrating substantial equivalence to already legally marketed predicate devices (Contour Midface Threads™, Contour Browlift Threads™, and Prolene™ Sutures). The key arguments are:
- Material Equivalence: The Contour Necklift Threads™ are made of the same polypropylene material as the predicate devices, which is a common and proven biocompatible material in medical applications.
- Technological Characteristics Equivalence: The polypropylene material has "proven to be biocompatible," and "Bench and animal evaluations have demonstrated the device to be safe and effective," with these characteristics being "the same for Surgical Specialties Corporation's Contour Threads as presented in the predicate 510(k)'s."
- Performance Testing: Physical testing for tensile strength (USP 27), force required to remove after implantation, and biocompatibility (ISO 10993) was conducted. While no specific numerical results are provided in this summary, the implication is that these tests met acceptable standards consistent with the predicate devices.
- Indications for Use Equivalence (with anatomical site variation): The necklift indication, while a different anatomical site than midface or browlift applications, is argued not to change the fundamental safety and effectiveness of the device given the material and design.
- Equivalence to Established Surgical Standard: The device's material (Prolene™ suture) is directly linked to a "Gold Standard Surgical Procedure for Necklift in the last 2 decades."
In essence, the "study" proving the device meets acceptance criteria is a demonstration that the new device is fundamentally the same as or very similar to previously cleared devices that have already been proven safe and effective through their own regulatory clearances and long-standing clinical use. No new, independent clinical study with a specific test set, ground truth experts, or statistical outcome metrics is detailed in this 510(k) summary.
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MAR 4 - 2005
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS 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: | January 31, 2005 |
| Name of Device: | Contour Necklift Threads™ |
| Common / UsualClassification Name: | GAWSuture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Contour Midface Threads™ K041593Contour Browlift Threads™ K042856Prolene™ Sutures N16374 |
| Indications For Use: | The Contour Necklift Thread™ is indicated for usein Necklift Surgery. The Necklift Contour Threadsare specifically indicated for use to fixate andelevate the subdermis to the deep fascia of theretromastoid area. |
Contour Necklift Threads™ Surgical Specialties Corporation
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Image /page/0/Picture/7 description: The image shows the logo for Sharpoint, a company that specializes in surgical tools. The logo features the word "Sharpoint" in a stylized font, with the registered trademark symbol next to it. To the right of the word is a black triangle pointing to the right. Below the word "Sharpoint" is the tagline "The Surgeon's Edge" in a smaller font.
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Image /page/1/Picture/0 description: The image shows the logo for Surgical Specialties Corporation. The logo features the words "Surgical Specialties" in a stylized font, with a black triangle to the right. Below the main text, it says "Corporation" and "Incision & Healing Technologies" in smaller fonts. There is also a handwritten "K050247" and "P2/3" at the top of the image.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Device Description | The Contour Necklift Threads™ are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture. The 25centimeter length thread incorporates a unidirectional barbed section 10 centimeters long from the distal end. The Threads will have a 7inch straight needle attached to the distal end and a 26 mm curved needle attached to the proximal end. The threads are supplied sterile for single use. |
|---|---|
| Technological Characteristics: | The Polypropylene material used for the Contour Necklift Threads™ is commonly used in medical applications and has been proven to be biocompatible. Bench and animal evaluations have demonstrated the device to be safe and effective. These characteristics are the same for Surgical Specialties Corporation's Contour Threads as presented in the predicate 510 (k)'s. There is no change in chemistry, material or composition. |
| Performance Data | Physical testing was conducted on the thread to USP 27 tensile strength, force required to remove after implantation and Biocompatibility for permanent implantation, ISO 10993. |
Image /page/1/Picture/4 description: The image shows the word "LOOK" in bold, black letters. To the right of the word is a black circle with white swirls inside. Below the word "LOOK" is the phrase "Precisely what you need" in a smaller font. The letters are all capitalized except for the "o" in "what", the "y" in "you", and the "n" in "need".
100 Dennis Drive · Reading, PA · 19606, U.S.A. 610 404-1000 • 800 523-33332 • Fax: 610 404-4010 www.surgicalspecialties.com
Image /page/1/Picture/6 description: The image contains the word "Sharpoint" in a stylized font, with the registered trademark symbol to the right of the word. Below "Sharpoint" is the phrase "The Surgeon's Edge" in a smaller font. To the right of the word "Sharpoint" is a black triangle pointing to the right. Below the text is the number 9 in a handwritten style.
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Substantial Equivalence
The Contour Necklift Thread™ is equivalent in the intended use to the predicate devices,The Contour Midface and Browlift Threads. The Contour Necklift Threads uses the same suture material as the predicate devices, Contour Midface and Browlift Threads. The use in different anatomical sites for the Necklift, Brow lift and Midface applications does not change the safety and effectiveness.
The Contour Necklift Threads also have a predicate device in the use of the PROLENE suture for what has been established as a safe and effective Gold Standard Surgical Procedure for Necklift in the last 2 decades, as described in this submission. The substantial equivalence determination is equivalent for these indications.
Image /page/2/Picture/4 description: The image shows the word "LOOK" in bold, sans-serif font. To the right of the word "LOOK" is a circular graphic with a spiral design inside. Below the word "LOOK" is a line of smaller text that is difficult to read due to its size and resolution. The overall design appears to be a logo or branding element.
100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 · 800 523-3332 · Fax: 610 404-4010 www.surgicalspecialties.com
Image /page/2/Picture/6 description: The image shows the word "Sharpoint" in a stylized font, with a registered trademark symbol next to it. To the right of the word is a black triangle pointing to the right. Below the word "Sharpoint" is the phrase "The Surgeon's Edge" in a smaller font. The number 10 is written in the bottom right corner of the image.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K050247
Trade/Device Name: The Contour Necklift Threads™ Regulation Number: 21 CFR 878.5010 Regulation Name: Non-absorbable synthetic polypropylene suture Regulatory Class: II Product Code: GAW Dated: January 31, 2005 Received: February 2, 2005
Dear Ms. Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became 37 (4) pe 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 encroours for regardy and the Medical Device Amendments, or to comments provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recurse in assess approval of a premarket approval application (PMA). and Cosmetic rice (11ct) that as nover subject to the general controls provisions of the Act. The T ou may, therefore, manel the Act include requirements for annual registration, listing of general controls profitive of ractice, 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 (500 a0070) als. Existing major regulations affecting your device can may be subject to subli adaterial egulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of Founts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advised that I Drivised or our device complies with other requirements of the Act mat 1 127 has made a aoth regulations administered by other Federal agencies. You must of any rederal statutes and regarants ancluding, but not limited to: registration and listing (21 comply with an the Her 812 CFR Part 801); good manufacturing practice requirements as set CITN Fatt 807), labeling (21 CFR Part 820); and if applicable, the electromic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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) This letter will anow you to begin makemig your averal equivalence of your device to a legally premarket notification. The PDA miding of sacolantial of 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
s and the many of the comments of the cases the recultion antitled If you desire specific advice for your ac not (240) 276-0115. Also, please note the regulation entitled, contact the Office of Complanes at (210) 215 Part 807.97). You may obtain " Misoranding by reference to premantee notifican under the Act from the Division of Snall other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Absociates of the Manufactures html.
Sincerely yours.
Muriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko50247
Indications for Use
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510(k) Number (if known):
Device Name: The Contour Necklift Threads™
Indications For Use:
The Contour Necklift Threads™ are indicated for use in Necklift surgery. The Contour Necklift Threads - are incollected for use to fixate and The Contour Necklift Throuds - and Subdermis to the retromastoid area.
Muriam C Phurst
(Division Sign-Division of General, Restorative, and Neurological Devices
$10(k) Number K650247
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)
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Image /page/5/Picture/16 description: The image shows the word "LOOK" in bold, black letters. To the right of the word is a black circle with a white swirl design inside. Below the word "LOOK" is the phrase "Precisely what you need" in a smaller, lighter font. The logo appears to be for a company or product named "LOOK".
100 Dennis Drive · Reading, PA 19606, U.S.A. 610 404-1000 - 800 523-3332 - Fax: 610 404-4010 www.surgicalspecialties.com
Sharpoint®
The Surgeon's Edge
§ 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.