(230 days)
Not Found
No
The document describes a surgical suture with barbs for tissue approximation and an antibacterial agent. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is a surgical suture used for soft tissue approximation, which is a tool for medical procedures rather than a device designed to deliver therapy.
No
This device is a surgical suture used for soft tissue approximation, not for diagnosing conditions. Its intended use is to physically hold tissue together.
No
The device description clearly indicates it is a physical surgical suture made of absorbable material with barbs and needles, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "soft tissue approximation where the use of absorbable sutures is appropriate." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "barbed suture material, armed with a surgical needle on each end." This is a surgical tool used to close wounds or approximate tissue during surgery.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. 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 Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory performance testings were performed to demonstrate that STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. These testings were performed in accordance with FDA's guidance document: "Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff" issued on June 3, 2003. Bench and Animal testings show that the device performed as intended and as claimed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA (U.S. Food & Drug Administration) logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
September 24, 2020
Ethicon, Inc. Joice Pappan Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K192144
Trade/Device Name: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device
Dear Mr. Joice Pappan:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 25, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov.
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 25, 2020
Ethicon, Inc. Joice Papan Regulatory Affairs Manager Route 22 West. P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K192144
Trade/Device Name: STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: February 21, 2020 Received: February 24, 2020
Dear Mr. Papan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury -S
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K192144
Device Name
STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is in large, red, sans-serif font, with ", INC." in a smaller font to the right. Below the main logo is the text "a Johnson & Johnson company" in a cursive font. The logo is simple and clean, with a focus on the company name.
510(k) Summary
| Submitter: | Ethicon, Inc., a Johnson & Johnson company
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876-0151
USA |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joice Pappan
Regulatory Affairs Manager
Ethicon, Inc., a Johnson & Johnson company
Ph: (908) 218-2113
Fax: (908) 541-3868
Email: Jpappan@its.jnj.com |
| Date Prepared: | March 20, 2020 |
| Device Trade Name: | STRATAFIX™ Spiral PDS™ Plus Bidirectional
Knotless 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 Devices | 510(k) Number |
|---|---|
| STRATAFIXTM Spiral PDSTM Plus Knotless Tissue Control Device | |
| (Primary) | K182873 |
| Secondary: QuillTM PDO Knotless Tissue Closure Device | K120827 |
5
Image /page/5/Picture/0 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in red, with the letters in a bold, sans-serif font. To the right of the word "ETHICON" is the word ",INC." in a smaller, sans-serif font. Below the word "ETHICON" is the phrase "a Johnson & Johnson company" in a cursive font.
Device Description:
The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. 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 Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.
While the formation of barbs in the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduces their effective strength. For this reason, the strength of the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDSTM Plus Bidirectional Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm. The actual diameter of the non-barbed section fiber is one size greater than the designated size with a maximum overage of 0.1 mm.
The USP and EU Pharmacopoeia sizes of the STRATAFIX™ Spiral PDS™ Plus Bidirectional Device are further defined in Table 1.
| USP DEVICE
SIZE
DESIGNATION | EU
PHARMACOPOEIA
DEVICE SIZE | STRATAFIX™ Spiral PDS™ Plus
Bidirectional | |
|-----------------------------------|------------------------------------|----------------------------------------------|-------------------|
| | (Metric / Ph. Eur.)
DESIGNATION | USP | Metric / Ph. Eur. |
| 1 | 4 | 1 | 4 |
| 0 | 3.5 | 0 | 3.5 |
| 2-0 | 3 | 2-0 | 3 |
| 3-0 | 2 | 3-0 | 2 |
| 4-0 | 1.5 | 4-0 | 1.5 |
Table 1. Diameter Comparison
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Image /page/6/Picture/0 description: The image contains the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif font, with the ", INC." in a smaller font size. Below the company name is the text "a Johnson & Johnson company" in a cursive font.
Tensile Strength:
STRATAFIX™ Spiral PDS™ Plus Bidirectional Device straight tensile strength meets the knot tensile strength for a USP and EU Pharmacopoeia polydioxanone device of the equivalent size as shown in Table 2.
Table 2. Tensile Strength Comparison
| USP DEVICE SIZE
DESIGNATION | EU
PHARMACOPOEIA
DEVICE SIZE
(Metric / Ph. Eur.)
DESIGNATION | Device Minimum
Knot Tensile Strength | |
|--------------------------------|--------------------------------------------------------------------------|-----------------------------------------|--------------------------|
| | | USP (kgf) | Metric /
Ph. Eur. (N) |
| 1 | 4 | 5.08 | 50.8 |
| 0 | 3.5 | 3.90 | 39.0 |
| 2-0 | 3 | 2.68 | 26.8 |
| 3-0 | 2 | 1.77 | 17.5 |
| 4-0 | 1.5 | 0.95 | 9.32 |
Indications for Use:
STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Performance Data:
Non-clinical laboratory performance testings were performed to demonstrate that STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device conforms to the current USP Monograph for absorbable surgical sutures, except for diameter. These testings were performed in accordance with FDA's guidance document: "Class II Special Controls Guidance Document: Surgical Sutures - Guidance for Industry and FDA Staff" issued on June 3, 2003. Bench and Animal testings show that the device performed as intended and as claimed.
7
Image /page/7/Picture/0 description: The image shows the logo for Ethicon, Inc., a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters, with "INC." in smaller letters to the right. Below the company name is the text "a Johnson & Johnson company" in a cursive font. The logo is simple and clean, with a focus on the company name.
Summary of Technological Characteristics and Performance:
The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device has similar technological characteristics as the predicate devices. Like the currently marketed predicate devices, STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is a sterile, monofilament synthetic absorbable suture intended for the approximation of soft tissue that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. The STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The barbs in STRATAFIX™ Spiral PDSTM Plus Bidirectional Device allow the tissue approximation without the need to tie surgical knots.
STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device will be available as a suture product with IRGACARE ®* MP, an antibacterial agent same as STRATAFIXTM Spiral PDSTM Plus Unidirectional predicate device.
Substantial Equivalence :
STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device has the same intended use and indications for use as the predicate devices. The technological differences between the subject device and the predicate devices raise no new questions of safety or effectiveness. STRATAFIX™ Spiral PDSTM Plus Bidirectional Knotless Tissue Control Device meets all criteria to demonstrate substantial equivalence to the predicate devices.
Conclusion:
Based on the intended use, technological characteristics, safety and performance testing, STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device has shown to be appropriate for its intended use and is substantially equivalent to the predicate devices.
- Trademark IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"