(98 days)
Featherlift Aptos Extended Length Threads are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
The threads are a blue, nonabsorbable, sterile, surgical strand of polypropylene. The product is USP size 2-0 polypropylene suture material 25 centimeters in length and incorporates a unidirectional-cogged section 10 centimeters long from the distal end. A 2 ¾ straight taper cutting needle made of 400 series stainless steel will be swedged to the proximal end. An introducer made of 18 gauge stainless steel will be included for placement of the Threads. The threads and the introducer are supplied sterile for single use.
The provided text is a 510(k) summary for a medical device called "Featherlift™ Extended Length Aptos Threads". This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
Preamble:
It's important to note that this 510(k) submission focuses on demonstrating substantial equivalence to an existing predicate device (Coapt Endotine Midface ST 4.5 device K032698), not on meeting specific, quantitative performance criteria derived from a primary clinical study with defined acceptance thresholds as one might see for a novel device or software. The "performance data" mentioned refers to bench and animal testing comparing the new device to standards, not human clinical trials with specific statistical endpoints to prove new clinical efficacy beyond what is already accepted for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, there isn't a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial proving a specific efficacy or accuracy metric. Instead, the document highlights how the Featherlift™ Threads are equivalent to the predicate device in terms of intended use, indications for use, and safety, while also pointing out some advantages.
The "performance data" section states:
- "Physical testing was conducted on the thread to USP 27 for tensile strength, force required to remove after implantation and Biocompatability for permanent implantation, ISO 10993."
- These are bench and animal evaluations, not human clinical performance data against specific acceptance criteria for clinical outcomes. The document does not provide the specific quantitative results of these tests or explicit "acceptance criteria" for them beyond adhering to USP and ISO standards.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable. The document describes bench and animal testing (physical testing, biocompatibility), not a clinical "test set" from human data. The provenance of the animal data is not specified (e.g., country of origin).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. There was no human clinical "test set" and thus no ground truthing by human experts for clinical outcomes. The testing was physical and biocompatibility testing.
4. Adjudication Method for the Test Set
This is not applicable, as there was no human clinical "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This device is a polypropylene suture for midface suspension, not an imaging or diagnostic device that would typically involve an MRMC study with human readers.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. This is a physical medical device (suture), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the performance data referenced relates to:
- USP 27 standards for tensile strength and force required to remove after implantation.
- ISO 10993 standards for biocompatibility for permanent implantation.
- For the core substantial equivalence argument, the "ground truth" is established by showing similarity in intended use, indications for use, and technological characteristics to the predicate device (Coapt Endotine Midface ST 4.5 device K032698), which has already been deemed safe and effective.
8. Sample Size for the Training Set
This is not applicable, as there is no "training set" in the context of this physical device's 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set."
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SEP 2 0 2004
K041593 P,1/3
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter:Address: | Surgical Specialties Corporation100 Dennis DriveReading, PA 19606 |
|---|---|
| Telephone:Contact Person: | 610 404 1000, ext. 2231Betty LazaroRegulatory Affairs Specialtist |
| Date Prepared: | June 10, 2004 |
| Name of Device: | FeatherliftTM Extended Length Aptos Threads |
| Common / UsualClassification Name: | GAWSuture, Non Absorbable, Synthetic, Polypropylene |
| Predicate Device: | Coapt Endotine Midface ST 4.5 device K032698 |
| Indications For Use: | Featherlift Aptos Extended Length Threads areindicated for use in midface suspension surgery tofixate the cheek subdermis in an elevated position. |
Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation
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K041593
p2/3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Device Description | The threads are a blue, nonabsorbable, sterile,surgical strand of polypropylene. The product isUSP size 2-0 polypropylene suture material 25centimeters in length and incorporates aunidirectional-cogged section 10 centimeters longfrom the distal end. A 2 ¾ straight taper cuttingneedle made of 400 series stainless steel will beswedged to the proximal end. An introducer madeof 18 gauge stainless steel will be included forplacement of the Threads. The threads and theintroducer are supplied sterile for single use. |
|---|---|
| Technological Characteristics: | The Polypropylene sutures used PMA 870064,K904906 for the fabrication of FeatherLift™Extended Length Aptos Threads are commonlyused in medical applications where they areimplanted for tissue approximation in the bodyindefinitely. Bench and animal evaluations havedemonstrated the Featherlift Extended LengthAptos Threads to be safe and effective. |
| Performance Data: | Physical testing was conducted on the thread toUSP 27 for tensile strength, force required toremove after implantation and Biocompatability forpermanent implantation, ISO 10993. |
Featherlift™ Extended Length Aptos Threads Surgical Specialties Corporation
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Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text starts with the letters "Koy" followed by what looks like "D593". There is also a fraction-like expression of "3/3" with a subscripted "3" before the fraction.
Substantial Equivalence
The Featherlift™ Extended Length Aptos Thread is I no I can in use as its predicate device Endotine equivalent in 4.5 having the same intended use and indication for use except for the surgical technique of subperiosteal deployment. The fixation of subcutaneous tissue and elevation for both devices are achieved by tacking to the temporal fascia. They are anchored by suturing and tying to that fascia. The fixation surface area of the Featherlift Aptos Thread is more uniform, spread out over the entire midface providing a greater surface area of fixation compared to the Endotine Midface. The Material of the Featherlift Aptos Thread is made from a non absorbable polypropylene suture and will maintain its fixation indefinitely compared to the midface suspension device that is fabricated from a PGA equivalent material that looses significant strength and mass by 5 months. Therefore, the Featherlift Aptos Thread is substantially equivalent and offers some advantages over the predicate device, the Endotine Midface ST4.5.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2004
Mr. Richard G. Jones Vice President, Regulatory Affairs/Quality Assurance Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606
Re: K041593
Ro41973
Trade/Device Name: Featherlift™ Extended Length Aptos Thread Regulation Number: 21 CFR 878.5010 Regulation Name: Polypropylene suture Regulatory Class: II Product Code: GAW Dated: September 7, 2004 Received: September 9, 2004
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave levice your bected. B read free is substantially equivalent (for the indications relerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manatise posice Americal Device American son to commerce prior to May 20, 1978, the exactions of the Federal Food, Drug, devices that have been resulted in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that to not require appt to the general controls provisions of the Act. The 1 ou may, mercrore, manel are act include requirements for annual registration, listing of general controls provisions of the rice, 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 (socure) inc. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overnents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri 3 issuaired or wouldevice complies with other requirements of the Act that I DA has made a decemmations administered by other Federal agencies. You must of any I cutures and regarance and regarants aincluding, but not limited to: registration and listing (21 Comply with an the Her Prequents (1) ); good manufacturing practice requirements as set OF It in the quality systems (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 - Mr. Richard G. Jones
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 marketing your ence of your device to a legally premarket notheadon: "The FDA midning of basification 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 ac not on one of the more the regulation entitled, and Colliact the Office of Compuner as (be notification" (21CFR Part 807.97). You may obtain Misoranumly by reference to premansonsibilities under the Act from the Division of Small other gelleral information on your respendent Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
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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K04/593.
Page 6 revised
Indications for Use
510(k) Number (if known):
Device Name: Featherlift™Extended Length Aptos Thread
Indications For Use:
The Featherlift™Extended Length Aptos Thread is 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of _ 1 ________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.