(90 days)
Not Found
No
The device description focuses on the material composition and mechanical design of the sutures, with no mention of AI or ML capabilities.
Yes
The device, a surgical suture, is intended for "general soft tissue approximation" to aid in the healing process, aligning with the definition of a therapeutic device.
No
This device is indicated for "general soft tissue approximation," meaning it is used for surgical closing of wounds and incisions, not for diagnosis.
No
The device description clearly details physical components like absorbable threads, anchors, surgical needles, and fixation tabs, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure for joining tissues, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics of the device, which is a barbed suture material with a needle and fixation tab/loop. This is consistent with a surgical tool, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: The text 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a surgical suture designed to physically approximate tissue.
N/A
Intended Use / Indications for Use
STRATAFIXTM Symmetric PDS Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
STRATAFIX Spiral PDS Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device 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, GAM
Device Description
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3)x. The device contains IRGACARE MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
STRATAFIX Spiral PDS Plus Knotless Tissue Control 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 PDS Plus Knotless Tissue Control 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 Knotless Tissue Control 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 PDS Plus 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 PDS Plus Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX Spiral PDS Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360ug/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX Spiral MONOCRYL 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 MONOCRYL 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 MONOCRYL 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 MONOCRYL Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX Spiral MONOCRYL Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX Spiral MONOCRYL Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX Spiral MONOCRYL 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 MONOCRYL Device is designed to anchor with a closed loop at one end and unidirectional barbed section on the other end. The STRATAFIX Spiral MONOCRYL Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2019
Ethicon, Inc. Dr. Ariell Joiner Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876
Re: K182873
Trade/Device Name: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW, GAM Dated: October 11, 2018 Received: October 12, 2018
Dear Dr. Joiner:
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cynthia Chang -S
for
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
2
510(k) Number (if known)
Device Name
STRATAFIXTM Symmetric PDSTM Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration. Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Number (if known)
Device Name
STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Number (if known)
Device Name
STRATAFIXTM Spiral MONOCRYL™ Plus Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
ft tissue
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
5
510(k) Number (if known)
Device Name
STRATAFIX™ Spiral MONOCRYLTM Knotless Tissue Control Device
Indications for Use (Describe)
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device 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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
ETHICON a Johnson shiron company
510(k) Summary
| Submitter: | Ethicon, Inc. a Johnson & Johnson company |
|---|---|
| P.O. Box 151 | |
| Route 22 West | |
| Somerville, NJ 08876-0151 | |
| Contact Person: | Ariell Joiner |
| Regulatory Affairs Specialist | |
| Phone: 908-218-2348 | |
| Fax: 908-218-2595 | |
| Email: ajoiner@its.jnj.com | |
| Date Prepared: | January 07, 2019 |
| Device Trade Name: | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Suture, Surgical, Absorbable Polydioxanone |
| Class: | II |
| Classification: | 21 CFR 878.4840 – Absorbable Polydioxanone Surgical Suture |
| Product Code: | NEW |
| Panel: | General and Plastic Surgery Devices |
| Device Trade Name: | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue
Control Device and
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control
Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Suture, Surgical, Absorbable, Polyglycolic Acid |
| Class: | II |
| Classification: | 21 CFR 878.4493 – Absorbable poly(glycolide/l-lactide)
Surgical Suture |
| Product Code: | GAM |
| Panel: | General and Plastic Surgery Devices |
7
Predicate Devices:
| Device | Product Code | 510(k) Number | Predicate for |
|---|---|---|---|
| STRATAFIX™ Symmetric | |||
| PDS™ Plus Knotless Tissue | |||
| Control Device | NEW | K141776 | Fundamental Scientific |
| Technology, Design, Intended | |||
| Use, Materials, Construction, | |||
| Performance Characteristics | |||
| STRATAFIX™ Spiral PDS™ | |||
| Plus Knotless Tissue Control | |||
| Device | NEW | K150670 | Fundamental Scientific |
| Technology, Design, Intended | |||
| Use, Materials, Construction, | |||
| Performance Characteristics | |||
| STRATAFIX™ Spiral | |||
| MONOCRYL™ Plus Knotless | |||
| Tissue Control Device and | |||
| STRATAFIX™ Spiral | |||
| MONOCRYL™ Knotless | |||
| Tissue Control Device | GAM | K151200 | Fundamental Scientific |
| Technology, Design, Intended | |||
| Use, Materials, Construction, | |||
| Performance Characteristics |
Device Description:
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from the polyester, poly (pdioxanone). The empirical molecular formula of the polymer is (C+HgO3). The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device is dyed with D&C Violet No. 2.
STRATIX™ Symmetric PDS™ Plus Knotless Tissue Control Device consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. Polydioxanone has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control 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 PDSTM Plus Knotless Tissue Control Device is designed to
8
anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control 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 PDS™ Plus 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 Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are used to describe the STRATAFIX™ Spiral PDS™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE® MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360ug/m. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ 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 MONOCRYL™ 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 MONOCRYL™ 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 MONOCRYL™ Plus Device reduces the tensile strength relative to non-barbed suture material of the same size, tying knots in nonbarbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Plus Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Plus Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is a monofilament. synthetic absorbable device prepared from a copolymer of glycolide and e-caprolactone. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral MONOCRYL™ 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 MONOCRYL™ Device is designed to anchor with a closed loop at one end and unidirectional barbed section on the other end. The STRATAFIX™ Spiral MONOCRYL™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
9
While the formation of barbs in the STRATAFIX™ Spiral MONOCRYL™ Device reduces tensile strength relative to non-barbed suture material of the same size, tving of knots in non-barbed suture materials also reduces their effective strengths. For this reason, the strength of the STRATAFIX™ Spiral MONOCRYL™ Device can be compared to USP knot strength of non-barbed sutures. USP designations for diameter are used to describe the STRATAFIX™ Spiral MONOCRYL™ Device suture material after barbing, except for minor variation in suture diameter with a maximum overage of 0.1mm.
Indications for Use:
The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Summary of Technological Characteristics:
The technological characteristics of the subject devices are identical to their predicate devices, therefore performance data are not necessary to establish substantial equivalence.
The STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K141776), are antibacterial, absorbable, dyed (violet) monofilaments prepared from the polyester, poly (pdioxanone), with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other to allow for tissue approximation without the need to tie surgical knots.
The STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIXTM Spiral PDS™ Plus Knotless Tissue Control Device (K150670), are both antibacterial, absorbable, dyed (violet) monofilaments prepared from the polyester, poly (pdioxanone), designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.
The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and its predicate device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (K151200), are both antibacterial, absorbable, undyed monofilaments prepared from a copolymer of glycolide and e-caprolactone, designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.
10
The STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and its predicate device, STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device (K151200), are both absorbable, undyed monofilaments prepared from a copolymer of glycolide and ecaprolactone, designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end to allow tissue approximation without the need to tie surgical knots.
Substantial Equivalence:
The subject devices are identical to their respective predicate devices with respect to functionality, technological characteristics, intended uses, and indications. There are no changes to the material, device construction, performance specifications, sterilization or manufacturing processes, or shelf life of the currently marketed devices. The subject devices differ from their respective predicate devices only in the labeling (Instructions for Use).
The Instructions for Use of the subject device, STRATAFIX™ Symmetric PDS™M Plus Knotless Tissue Control Device, has been revised to add the following three new Warnings to the Warnings Section:
-
- Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.
-
- Avoid contacting STRATAFIX™ Device and associated needles with other materials (e.g. surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs.
-
- Small bowel obstruction (SBO): including volvulus, bowel infarction, and significant morbidity, have been reported due to barbed suture ends hooking onto adjacent small bowel and/or mesentery, such as in peritoneal closure.
The Instructions for Use of the subject devices, STRATAFIX™ Spiral PDSTM Plus Knotless Tissue Control Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device have been revised to move one Precaution statement, "Avoid contacting the STRATAFIX™ Device and associated needles with other materials (e.g. surgical gauze, etc.) in the surgical field to prevent ensnaring on the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs" to the Warnings Section and add the following two Warnings to the Warnings Section:
-
- Care should be undertaken to avoid leaving barbed suture ends adjacent to the peritoneum in extra-peritoneal tissue closure.
-
- Small bowel obstruction (SBO): including volvulus, bowel infarction, and significant morbidity, have been reported due to barbed suture ends hooking onto adjacent small bowel and/or mesentery, such as in peritoneal closure.
11
The subject devices do not raise new questions of safety or effectiveness and are therefore substantially equivalent to their respective predicate devices.
Conclusion:
Based on the intended use, fundamental scientific technology and, technological characteristics, the subject devices, STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device, STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device, and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device are considered to be substantially equivalent to their predicate devices. STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device (K141776), STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device (K150670), and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device and the STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device (K151200), respectively.
- Trademark
IRGACARE®* MP (triclosan) "Registered Trademark of BASF Group"