(108 days)
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The STRATAFIX™ Spiral PDS™ Plus Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTN Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDS™ Plus Device can be compared to USP knot strength of nor-broad sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
The provided document is a 510(k) premarket notification for a medical device (STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device). While it details the device description, indications for use, and a general statement about performance data, it does not contain detailed acceptance criteria or the specific results of a study in a manner that allows for a direct population of the requested table.
Here's an analysis based on the available information, highlighting what the document provides and what it omits:
1. A table of acceptance criteria and the reported device performance
The document states: "Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter." And "STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device met all testing criteria to demonstrate substantial equivalence to the predicates devices."
This indicates that the acceptance criteria are based on the USP Monograph for absorbable surgical sutures (with a noted exception for diameter) and likely additional criteria to show equivalence to predicate devices. However, the exact numerical or qualitative acceptance criteria and the corresponding reported performance values are not detailed in this summary. It's a high-level statement of compliance.
Therefore, a table cannot be fully populated with specific criteria and performance values from this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document.
- Data provenance: "Non-clinical laboratory performance testing" and "bench and animal testing" are mentioned. The document is a submission to the US FDA, so the testing was likely conducted in compliance with US regulatory standards, but the physical location/country of origin of the labs is not stated. Whether it was retrospective or prospective is also not mentioned, but given it's "performance testing," it would inherently be prospective for the purpose of demonstrating device performance.
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)
This type of information is not applicable to this document. The device is a surgical suture, and the performance testing mentioned (USP monograph, bench, and animal testing) does not involve human expert interpretation of data points that would require "ground truth" establishment by medical experts in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the reasons in 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-assisted diagnostic device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a surgical suture, "ground truth" would relate to its physical and biological performance. The document implies the "ground truth" or standard for performance is based on:
- USP Monograph for absorbable surgical sutures: This outlines standardized physical and chemical properties.
- Bench testing: In vitro evaluation of mechanical properties.
- Animal testing: In vivo assessment of tissue reaction, absorption, and performance in a biological system.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable for the reasons in point 8.
In summary, the provided document is a regulatory submission for a physical medical device (suture) and therefore lacks the detailed information on statistical studies, expert ground truth, and AI-specific performance metrics that would be relevant for an AI/diagnostic device. The "study" mentioned is general performance testing against established standards (USP Monograph) and comparison to predicate devices for substantial equivalence.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Ethicon Incorporated a Johnson & Johnson company Ms. Donna Marshall Manager of Regulatory Affairs P.O. Box 151 Route 22 West Somerville, New Jersey 08876
Re: K150670
Trade/Device Name: STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: June 4, 2015 Received: June 5, 2015
Dear Ms. Marshall:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150670
Device Name
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
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Traditional 510(k) STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device Ethicon, Inc.
company
510(k) Summary
Submitter:
Ethicon Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151 USA
Contact Person:
Donna Marshall Manager, Regulatory Affairs Ethicon, Inc. a Johnson & Johnson company Ph: (908) 541-3990 Fax: (908) 218-2595 e-mail: dmarsha2@its.jnj.com
| Date Prepared: | March 13, 2015 |
|---|---|
| Device Trade Name: | STRATAFIX™ Spiral PDS™ PlusKnotless Tissue Control Device |
| Device Common Name: | Suture, Surgical, Absorbable, Polydioxanone |
| Class: | II |
| Classification Name: | Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840) |
| Product Code: | NEW |
| Predicate Device | 510(k) Number |
|---|---|
| PDSTM Plus Antibacterial (polydioxanone) Suture | K061037 |
| Ouill™ PDO Knotless Tissue Closure Device, Variable | K123877 |
| K113744 | |
| Loop (polydioxanone) | K132268 |
| Ouill™ PDO Knotless Tissue Closure Device | K120827 |
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Traditional 510(k) STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device Ethicon. Inc.
Device Description:
The STRATAFIX™ Spiral PDS™ Plus Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HgO3)x. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, Variable Loop Design consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PDSTN Plus Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in nonbarbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDS™ Plus Device can be compared to USP knot strength of nor-broad sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
Indications for Use:
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Performance Data:
Non-clinical laboratory performance testing was performed demonstrating that STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. In addition, bench and animal testing was provided showing that the device performed as intended and as claimed.
Summary of Technological Characteristics and Performance Testing:
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device has similar technological characteristics as the predicate devices. Like the currently marketed devices, STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is a sterile, monofilament synthetic absorbable suture intended for the approximation of soft tissue that conforms to the
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Traditional 510(k) STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device Ethicon, Inc.
USP Monograph for absorbable surgical sutures, except for diameter. Similar to the currently USP Monograph for absorbable surgiour stares, Shoop™ Plus Knotless Tissue Control Device marketed I Do I tus suture, SToduct with IRGACARE ®* MP, an antibacterial agent.
Substantial Equivalence:
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device has the same intended use STRATATIA - Spiral PDS - 11th predicate devices. The technological differences between and similar includions for ass the piral PDSTM Plus Knotless Tissue Control Device and the the subject devices raise no new questions of safety or effectiveness. STRATAFIX™ Spiral production of need from quest Device met all testing criteria to demonstrate substantial equivalence to the predicates devices.
Conclusion:
Based on the intended use, technological characteristics, safety and performance testing STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device has been shown to be STRATATIA - Spiral I Do - Frus Hillonsidered to be substantially equivalent to the predicate devices.
* Trademark
" IRGACARE@* MP (triclosan) "Registered Trademark of BASF Group"
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.