(199 days)
Not Found
No
The device description and performance studies focus on the physical properties and standard testing of a surgical suture, with no mention of AI or ML.
No.
Surgical sutures are used to close wounds and hold tissues together, which is part of a surgical procedure, but they do not directly treat or prevent a disease or condition as a therapeutic device would. They are considered implantable accessories used in a therapeutic procedure.
No
Explanation: The device is a surgical suture, which is used for closing wounds and repairing tissues, not for diagnosing medical conditions. The "Intended Use / Indications for Use" section clearly states its purpose as a surgical implement.
No
The device description clearly states it is a physical surgical suture made of stainless steel, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MERISTEEL™ sutures are for surgical procedures on the human body (abdominal wounds closure, hernia repair, etc.). This is a therapeutic or surgical device, not a diagnostic one.
- Device Description: The description details a surgical suture made of stainless steel, used for physically joining tissues. This is consistent with a surgical device.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the body (blood, urine, tissue, etc.) to diagnose a condition or disease. IVDs are designed for this purpose.
- Performance Studies: The performance studies focus on the physical properties of the suture (diameter, tensile strength, needle attachment, length) and biocompatibility, which are relevant to a surgical implant/device. They do not involve diagnostic accuracy metrics.
Therefore, MERISTEEL™ sutures are a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
Product codes
GAO,GAQ
Device Description
MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel.
This suture is available undyed and uncoated.
MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes.
Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, sterna
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
The Surgical Suture was subjected to the performance testing as per USP requirements. The safety and effectiveness of the Surgical Suture has been evaluated for the following performance and safety requirements.
-
- Diameter USP
-
- Tensile strength USP
-
- Needle attachment USP
-
- Suture Length
-
- Biocompatibility as per ISO 10993-1
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.
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.
February 1, 2018
M/s. Meril Endo Surgery Private Limited Mr. Umesh Sharma Deputy General Manager - Quality Assurance Third Floor, E1-E3. Meril Park Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi District, Valsad, 396191 India
Re: K172146
Trade/Device Name: Meristeel Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAO Dated: December 29, 2017 Received: January 3, 2018
Dear Mr. Sharma:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
David Krause -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
Indications for Use
510(k) Number (if known) K172146
Device Name MERISTEEL
Indications for Use (Describe)
MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
| 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."
3
510(k) Summary
l. Submitter
M/s. Meril Endo Surgery Private Limited Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com E-mail: umesh.sharma@merillife.com
Contact Person: Umesh Sharma Date Prepared: June 21, 2017
II. Device
| Sr.
No. | Trade /
Proprietary Name | Common
Name | Classification
n | Regulatory Class | Product Code | Regulation Number | Review Panel |
|------------|----------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------------|--------------|-------------------|-----------------------------------------------------|
| 1. | Meristeel™
- Stainless Steel
Steel
Surgical
Suture | Stainless Steel
Surgical
Suture,
Non-Absorbable | Stainless Steel
Surgical
Suture,
Non-Absorbable | II | GAQ | 21 CFR 878.4495 | General &
Plastic
Surgery
Devices
Panel |
4
III. Predicate Device
Stainless Steel surgical suture (CP Medical) - (510k : K030351)
IV. Device Description
MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel.
This suture is available undyed and uncoated.
MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes.
Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands
V. Intended Use
MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.
VI. Substantial Equivalence
The device design, material of construction, performance, packaging and intended uses are substantial equivalence to the predicate device. Substantial equivalence is based on the following parameters:
-
- Product description
-
- Intended use
-
- Suture Size
-
- Single use
-
- Sterilisation method
5
-
- Packaging
-
- Label Claim
-
- Performance
- a. Diameter USP
- b. Tensile strength USP
- c. Needle attachment USP
- d. Suture Length
-
- Labelling and Instructions for use (IFU)
VII. Performance Data
The Surgical Suture was subjected to the performance testing as per USP requirements. The safety and effectiveness of the Surgical Suture has been evaluated for the following performance and safety requirements.
-
- Diameter USP
-
- Tensile strength USP
-
- Needle attachment USP
-
- Suture Length
-
- Biocompatibility as per ISO 10993-1
Conclusion VIII.
Meristeel™ Stainless Steel Sutures are substantially equivalent to currently marketed devices Stainless Steel surgical suture (CP Medical) - (510k: K030351) and present no substantial differences in design, material, intended use and function to predicate device.