(95 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of surgical sutures, with no mention of AI or ML technology.
Yes.
The devices are surgical sutures, which are used for "general soft tissue approximation and/or ligation." Healing damaged tissue is a therapeutic action.
No
Explanation: The provided text describes various types of sutures used for tissue approximation and ligation. There is no mention of these devices being used for diagnosis, only for surgical procedures.
No
The device description clearly outlines physical components such as sutures made of silk, polyamide, poly (ethylene terephthalate), and polypropylene, as well as needles and pledgets. There is no mention of software as a component of the device.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states that these devices are for use as non-absorbable sutures in general soft tissue approximation and/or ligation. This involves physically joining or tying off tissues within the body.
- Device Description: The descriptions detail the materials and construction of surgical sutures, which are physical implants or tools used during surgery.
- Lack of IVD Characteristics: There is no mention of these devices being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze biological samples. These devices are used inside the body during surgical procedures.
N/A
Intended Use / Indications for Use
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAP, GAR, GAT, GAW
Device Description
a. FILASILK™ Natural Non-absorbable Silk Surgical Suture
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums.
FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax.
FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
c. MERICRON XLTM Non Absorbable Polyester Surgical Suture
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture.
MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes
MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36.
PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue.
FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes
FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36.
PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue, skin tissue, cardiac, vascular, ophthalmic, cardiovascular, neurological.
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)
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
- a. In Vitro Cytotoxicity Study
- b. Skin Sensitization Study
- c. Intracutaneous Reactivity Test
- d. Acute Systemic Toxicity Study
- e. Sub Chronic Toxicity Study
- f. Intramuscular Implantation Test
- g. Bacterial Reverse Mutation Test
- h. Mammalian Erythrocyte Micronucleus Test
- In Vitro Hemolysis Test i.
- Pyrogen Test
Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes.
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
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.
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.
October 20, 2017
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, 396191 India
Re: K172149
Trade/Device Name: FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II
Product Code: GAP, GAR, GAT, GAW Dated: July 11, 2017
Received: July 17, 2017
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
1
manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) 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.
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name FILAMIDE
Indications for Use (Describe)
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name FILAPROP
Indications for Use (Describe)
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
| 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
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name FILASILK
Indications for Use (Describe)
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
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
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name MERICRON XL
Indications for Use (Describe)
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.
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
6
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: July 08, 2017
II. Device
| Sr. | Trade | Common | Classification | Regulatory | Product | Regulation | Review |
|---|---|---|---|---|---|---|---|
| No. | Proprietary | Name | Class | Code | Number | Panel | |
| Name | |||||||
| 1. | FILASILK™ | Natural | Suture, | ||||
| Non | = | GAP | 878.5030 | General | |||
| Natural Non- | Non- | absorbable, | & Plastic | ||||
| absorbable | absorbable | Silk | Surgery | ||||
| Surgical | |||||||
| Silk | Silk | ||||||
| Suture | Surgical | ||||||
| Suture | |||||||
| 2. | FILAMIDE™ | Non- | Suture, | ||||
| Non | GAR | 878.5020 | General | ||||
| Non | absorbable | absorbable, | & Plastic | ||||
| Absorbable | Polyamide | Synthetic, | Surgery | ||||
| Polyamide | Surgical | Polyamide | |||||
| Surgical | Suture | ||||||
| Sutures | |||||||
| 3. | MERICRON | Non | Suture, | ||||
| Non | = | GAT | 878.5000 | General | |||
| XLT" XLT" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" = "" | |||||||
| Non | absorbable | absorbable, | & Plastic | ||||
| Absorbable | Poly | Synthetic, Poly | Surgery | ||||
| Polyester | (Ethylene | (Ethylene | |||||
| Surgical | Terephthal | Terephthalate) | |||||
| Suture | ate) Suture | ||||||
| 4. | FILAPROP™ | Non- | Suture, | ||||
| Non | = | GAW | 878.5010 | General | |||
| Non | absorbable | absorbable, | & Plastic | ||||
| Absorbable | Polypropyl | Synthetic, | Surgery | ||||
| Polypropylene | ene | Polypropylene | |||||
| Surgical | Surgical | ||||||
| Suture | Suture |
7
III. Predicate Device
| Sr. No. | Meril's Suture Trade /
Proprietary Name | Predicate
Device Name | Predicate Device
510(k) No. |
|---------|--------------------------------------------------------------|--------------------------|--------------------------------|
| 1. | FILASILKTM Natural Non-
absorbable Silk Surgical Suture | FILASILKTM | K160623 |
| 2. | FILAMIDETM Non Absorbable
Polyamide Surgical Sutures | FILAMIDETM | K160623 |
| 3. | MERICRON XLTM Non
Absorbable Polyester Surgical
Suture | MERICRON XLTM | K160623 |
| 4. | FILAPROPTM Non Absorbable
Polypropylene Surgical Suture | FILAPROPTM | K160623 |
IV. Device Description
a. FILASILK™ Natural Non-absorbable Silk Surgical Suture
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums.
FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax.
FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
8
c. MERICRON XLTM Non Absorbable Polyester Surgical Suture
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture.
MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes
MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36.
PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue.
FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes
FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36.
PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
V. Intended Use
-
- FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
-
- FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
9
-
- MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
-
- FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
VI. Substantial Equivalence
The device design, material of construction, performance, packaging and intended uses are similar to the predicate device. Substantial equivalence is conducted based on the following parameters:
-
- Product description
-
- Intended use
-
- Suture Size
-
- Colorant Used Dye / Un-dyed
-
- Suture Coating
-
- Single use
-
- Sterilisation method
-
- Packaging
-
- Label Claim
-
- Performance
- a. Diameter USP
- b. Tensile strength USP
- c. Needle attachment USP
- d. Suture Length
-
- Labeling 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
- a. In Vitro Cytotoxicity Study
- b. Skin Sensitization Study
- c. Intracutaneous Reactivity Test
- d. Acute Systemic Toxicity Study
- e. Sub Chronic Toxicity Study
10
- f. Intramuscular Implantation Test
- g. Bacterial Reverse Mutation Test
- h. Mammalian Erythrocyte Micronucleus Test
- In Vitro Hemolysis Test i.
- Pyrogen Test ....
VIII. -Conclusion
Meril's Surgical Sutures are composed of the same materials, as are the predicate devices and has the same design, as do the predicate.
The subject devices are offered with the same colorants as predicate devices i.e. Logwood extract black used in FILASILK™ & FILAMIDE™ is in accordance to 21 CFR 73.1410, D&C Green No. 6 used in MERICRON XL™ is in accordance with 21 CFR 74.3206 & Phthalocyanine blue used in FILAPROP™ is in accordance with 21 CFR 74. 3045).
Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes.