(253 days)
No
The 510(k) summary describes a standard surgical suture made of a copolymer. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on material properties, biocompatibility, and mechanical strength, not on any analytical or predictive functions.
Yes
This device (surgical sutures) is used for "general soft tissue approximation and/or ligation." These actions fix or treat a medical condition, which aligns with the definition of a therapeutic device.
No
These devices are surgical sutures, used for tissue approximation and ligation during surgical procedures. They perform a therapeutic function by physically holding tissues together, rather than diagnosing a condition.
No
The device description clearly indicates that the device is a physical surgical suture made of a copolymer, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that these are "surgical sutures." Sutures are used within the body to approximate and ligate tissues.
- Intended Use: The intended use describes the application of the sutures in surgical procedures on soft tissues, skin, and mucosa. This is an in vivo (within the living organism) application, not an in vitro (in glass/outside the living organism) diagnostic test.
The information provided describes a medical device used for surgical procedures, not a diagnostic test performed on specimens.
N/A
Intended Use / Indications for Use
CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues.
CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Product codes
GAM
Device Description
The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are multifilament, braided, sterile synthetic absorbable surgical sutures composed of a copolymer of 90% glycolide and 10% L-lactide. The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are coated with copolymer of Poly(glycolide-co-L-lactide) (30/70) and calcium stearate.
The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color.
The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only.
The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached.
The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue, ophthalmic, superficial soft tissue of the skin and mucosa. Not for use in cardiovascular or neurological tissues.
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)
Non-Clinical Tests:
The testing demonstrated substantial equivalence of the CARESORB® - Polyglactin 910 Surgical Suture and CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Suture to the Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide predicate devices respectively. The testing was conducted on the final sterilized devices in accordance with the FDA Class II Special Controls Guidance Document: Surgical Sutures.
Performance Testing included:
- ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity, 2014
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity, 2009 (R) 2014
- ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects after Implantation, 2007 (R) 2014
- ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals, 2008 (R) 2012
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization, 2010 (R) 2014
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity, 2006 (R) 2010
- USP 39-NF33 Absorbable Surgical Suture, 2016
- USP 39-NF33 Sutures Diameter, 2016
- USP 39-NF33 Sutures Needle Attachment, 2016
- USP 39-NF33 Tensile Strength, 2016
- ISO 11607-1 Section 5.2 Whole package microbial aerosol challenge test, 2014
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials, 2015
- ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages, 2013
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test), 2011
- USP39-NF 34 Sterility Test, 2016
- USP39-NF 34 Bacterial Endotoxins Test, 2016
- ISO 15223-1 Third Edition 2016-11-01, Medical Devices Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements. (General I (QS/RM))
Key results:
- The biocompatibility test results demonstrated no evidence of cytotoxicity, irritation, delayed dermal sensitization or acute systemic toxicity for CARESORB® Surgical Suture.
- In the short-term, mid-term and long-term Intramuscular Implantation Tests with Histopathology, the CARESORB® Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ used as a control.
- In the mid-term Intramuscular Implantation Test with Histopathology, the CARESORB® Rapid Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ Rapide used as a control.
- The CARESORB® Suture was also found to be non-pyrogenic, non-mutagenic and non-genotoxic.
Resorption Profile:
- The resorption profiles of the final sterilized sutures were demonstrated in vivo.
- The CARESORB® sutures were compared to the predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures have similar tensile strength retention profile in comparison to the marketed predicate VICRYL™ sutures.
- The in-vivo breaking strength retention profile of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The resorption profile of CARESORB® RAPID was determined to be similar to that of the marketed predicate VICRYL™ Rapide.
- The resorption profile of the final sterilized CARESORB® RAPID suture was also demonstrated in vitro.
- The CARESORB® RAPID, sterilized by EtO, were compared to the predicate VICRYL™ Rapide sutures, sterilized by gamma irradiation, and to the raw material supplier's sutures, sterilized by gamma irradiation. All sutures were immersed in the phosphate buffer solution (pH 7.4) for 5, 14, 21 and 28 days and then tested for breaking strength retention at each time point. The study results demonstrated that all three sutures had essentially identical resorption profiles under the same study conditions and that tensile strength and tensile strength retention of CARESORB® RAPID was comparable to those of VICRYL™ Rapide and the raw material supplier's sutures.
- Additionally, the rate of absorption of CARESORB® sutures was compared to that of predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures and VICRYL™ sutures have very similar absorption in tissue.
- The rate of absorption of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The CARESORB RAPID rate of absorption in tissue was determined to be similar to that of the marketed predicate VICRYL™ Rapide.
Shelf Life:
- CARESORB® and CARESORB® RAPID sutures have been tested in real time stability studies as well as in the accelerated aging studies.
- The real time stability studies for both sutures were performed at 18°C to 26°C temperature and relative humidity of no more than 65%. The accelerated aging stability studies were performed at 68°C to 72°C temperature and relative humidity of no more than 65% for CARESORB® and at 53°C to 57°C temperature and relative humidity of no more than 65% for CARESORB® RAPID.
- The aged sutures were tested for parameters specified in the USP Monograph for Absorbable Surgical Sutures and other applicable requirements: Diameter (USP 39 ), Needle Attachment (USP 39 ), Tensile Strength (USP 39 ), In vitro Breaking Strength Retention (BSR), Visual Inspection, Moisture content, Sterility Testing (USP 39-NF34 ).
- The study results demonstrated conformance to the specified acceptance criteria and supported the 5 year expiration date assignment for CARESORB® and CARESORB® RAPID sutures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they also resemble an abstract bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2017
CPT Sutures Co., Ltd. % Ms. Natalya Valerio Official Correspondent for CPT Sutures Co., Ltd. MDI Consultants. Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021
Re: K170166
Trade/Device Name: CARESORB® - Polyglactin 910 Surgical Suture, CARESORB RAPID® - Polyglactin 910 (fast Absorbing) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 31, 2017 Received: September 1, 2017
Dear Ms. Valerio:
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (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. 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
510(k) Number (if known) K170166
Device Name CARESORB® - Polyglactin 910 Surgical Suture
Indications for Use (Describe)
CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues.
| 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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Indications for Use
510(k) Number (if known) K170166
Device Name
CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Suture
Indications for Use (Describe)
CARESORB® RAPID Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or 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
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
K170166 p. 1 of 7
510(k) SUMMARY
The assigned 510(k) number is: K170166
1. Submitter's Identification:
CPT Sutures Co., Ltd. 8 Dao Tri Street Phu Thuan Ward District 7, Ho Chi Minh, Vietnam
Date Summary Prepared: August 31, 2017
Mr. Khoa Do Contact: Vice Director CPT Sutures Co., Ltd. e-mail: khoa.do@cpt-medical.com phone: (+84) 28 38 222 228
2. Name of the Device:
| Trade Name: | CARESORB® - Polyglactin 910 Surgical Suture and
CARESORB® RAPID - Polyglactin 910 fast absorbing
Surgical Suture |
|--------------------|------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Regulation Number: | 21CFR 878.4493 |
| Regulation Name: | Absorbable Poly(glycolide/L-lactide) Surgical Suture |
| Regulatory Class: | Class II |
| Product Code: | GAM |
3. Information for the 510(k) Cleared Device (Predicate Device):
Ethicon's Coated VICRYL™ (Polyglactin 910) Synthetic Absorbable Suture, 510(k) # K022269
Ethicon's Coated VICRYL™ Rapide (Polyglactin 910) Synthetic Absorbable Suture, 510(k) # K033746
4. Device Description:
The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are multifilament, braided, sterile synthetic absorbable surgical sutures composed of a copolymer of 90% glycolide and 10% L-lactide. The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are coated with copolymer of Poly(glycolide-co-L-lactide) (30/70) and calcium stearate.
The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color.
5
The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only.
The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached.
The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.
5. Indications for Use:
CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues.
CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
| Comparison
Criteria | New Device
CARESORB® -
Polyglactin 910
Surgical Suture | New Device
CARESORB® RAPID -
Polyglactin 910
Surgical Suture | Predicate
Device(s) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device | Ethicon's Coated
VICRYL™ (Polyglactin
910) Synthetic
Absorbable Suture,
510(k) # K022269 | Ethicon's Coated
VICRYL™ Rapide
(Polyglactin 910)
Synthetic
Absorbable Suture,
510(k) # K033746 | Image: checkerboard pattern |
| Classification | Synthetic
Absorbable
Surgical Suture | Synthetic
Absorbable
Surgical Suture | Same |
| Indications
for Use | General soft tissue approximation and / or ligation, including use in ophthalmic procedures, but not in cardiovascular or neurological tissues | Superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required but not for use in ligation, ophthalmic, cardiovascular or neurological procedures | Same for each
respective
predicate |
| Suture Material | Copolymer of 90%
glycolide and 10%
L-lactide | Copolymer of 90%
glycolide and 10%
L-lactide | Same |
| Material
Presentation | Multifilament, braided | Multifilament, braided | Same for each
respective
predicate |
| Coating | Coated with copolymer
of Poly(glycolide-co-L-
lactide) (30/70) and
calcium stearate | Coated with copolymer
of Poly(glycolide-co-L-
lactide) (30/70) and
calcium stearate | Same |
| Color Additive | Available dyed with FDA-
approved color additive
D&C Violet No. 2 - Cl
60725 as well as undyed
in natural beige color | Available undyed only | Same for each
respective
predicate |
| Sterilization | Sterilized by
Ethylene Oxide | Sterilized by
Ethylene Oxide | VICRYL™ is
sterilized by
Ethylene Oxide
VICRYL™ Rapide
is sterilized by
Gamma Irradiation |
| Single Use | Yes | Yes | Same |
| How Supplied | Sutures of various
lengths and gauge sizes
of USP 6-0 to 1, with or
without the standard
stainless steel needle
(series 302 with silicon
coating) attached.
Available as one-dozen
and three-dozen boxes. | Sutures of various
lengths and gauge sizes
of USP 4-0 to 2-0, with
or without the standard
stainless steel needle
(series 302 with silicon
coating) attached.
Available as one-dozen
and three-dozen boxes. | Sutures of various
gauge sizes and
lengths, with or
without standard
stainless steel
needle attached.
Available as one-
dozen and three-
dozen boxes. |
| Absorption
Profile | Suture absorption begins
as a loss of tensile
strength followed by
eventual absorption by
hydrolysis. Complete
absorption occurs
between 56-70 days. | Suture absorption begins
as a loss of tensile
strength followed by
eventual absorption by
hydrolysis. Complete
absorption occurs in 42
days. | Same for each
respective
predicate |
| Breaking
Strength
Retention Profile | Percent Breaking
Strength Retention (%
BSR): > 65% at 14 days;
40% at 21 days. | Percent Breaking
Strength Retention (%
BSR): 50% at 5 days;
0% at 14 days. | Same for each
respective
predicate |
| Suture Diameter | Complies with
USP except for
slight oversize in the
suture diameter | Complies with
USP except for
slight oversize in the
suture diameter | Same |
| Suture Length | ≥ 95% of the claimed
label length as required
by USP | ≥ 95% of the claimed
label length as required
by USP | Same |
| Needle
Attachment | Complies with
USP | Complies with
USP | Same |
| Tensile Strength | Complies with
USP | Complies with
USP | Same |
| Biocompatibility | Complies with all ISO
10993-1 required tests
for absorbable surgical
sutures | Complies with all ISO
10993-1 required tests
for absorbable surgical
sutures | Same |
| Packaging | Validated sterile barrier
packaging system | Validated sterile barrier
packaging system | Same |
6
7
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence:
The below referenced testing demonstrated substantial equivalence of the CARESORB® - Polyglactin 910 Surgical Suture and CARESORB® RAPID -Polyglactin 910 (fast absorbing) Surgical Suture to the Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide predicate devices respectively. The testing was conducted on the final sterilized devices in accordance with the FDA Class II Special Controls Guidance Document: Surgical Sutures.
Performance Testing:
-
- ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity, 2014
-
- ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity, 2009 (R) 2014
-
- ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects after Implantation, 2007 (R) 2014
-
- ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals, 2008 (R) 2012
-
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization, 2010 (R) 2014
8
-
- ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity, 2006 (R) 2010
-
- USP 39-NF33 Absorbable Surgical Suture, 2016
-
- USP 39-NF33 Sutures Diameter, 2016
-
- USP 39-NF33 Sutures Needle Attachment, 2016
-
- USP 39-NF33 Tensile Strength, 2016
-
- ISO 11607-1 Section 5.2 Whole package microbial aerosol challenge test, 2014
-
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials, 2015
-
- ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages, 2013
-
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test), 2011
-
- USP39-NF 34 Sterility Test, 2016
-
- USP39-NF 34 Bacterial Endotoxins Test, 2016
-
- ISO 15223-1 Third Edition 2016-11-01, Medical Devices Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements. (General I (QS/RM))
The biocompatibility test results demonstrated no evidence of cytotoxicity, irritation, delayed dermal sensitization or acute systemic toxicity for CARESORB® Surgical Suture. In the short-term, mid-term and long-term Intramuscular Implantation Tests with Histopathology, the CARESORB® Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ used as a control. In the mid-term Intramuscular Implantation Test with Histopathology, the CARESORB® Rapid Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ Rapide used as a control.
The CARESORB® Suture was also found to be non-pyrogenic, non-mutagenic and non-genotoxic.
9
Resorption Profile:
The resorption profiles of the final sterilized sutures were demonstrated in vivo.
The CARESORB® sutures were compared to the predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures have similar tensile strength retention profile in comparison to the marketed predicate VICRYL™ sutures.
The in-vivo breaking strength retention profile of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The resorption profile of CARESORB® RAPID was determined to be similar to that of the marketed predicate VICRYL™ Rapide.
The resorption profile of the final sterilized CARESORB® RAPID suture was also demonstrated in vitro.
The CARESORB® RAPID. sterilized by EtO. were compared to the predicate VICRYL™ Rapide sutures, sterilized by gamma irradiation, and to the raw material supplier's sutures, sterilized by gamma irradiation. All sutures were immersed in the phosphate buffer solution (pH 7.4) for 5. 14. 21 and 28 days and then tested for breaking strength retention at each time point. The study results demonstrated that all three sutures had essentially identical resorption profiles under the same study conditions and that tensile strength and tensile strength retention of CARESORB® RAPID was comparable to those of VICRYL™ Rapide and the raw material supplier's sutures.
Additionally, the rate of absorption of CARESORB® sutures was compared to that of predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures and VICRYL™ sutures have very similar absorption in tissue.
The rate of absorption of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The CARESORB RAPID rate of absorption in tissue was determined to be similar to that of the marketed predicate VICRYL™ Rapide.
Shelf Life:
CARESORB® and CARESORB® RAPID sutures have been tested in real time stability studies as well as in the accelerated aging studies.
The real time stability studies for both sutures were performed at 18°C to 26°C temperature and relative humidity of no more than 65%. The accelerated aging stability studies were performed at 68°C to 72°C temperature and relative humidity of no more than 65% for CARESORB® and at 53°C to 57°C temperature and relative humidity of no more than 65% for CARESORB® RAPID.
The aged sutures were tested for parameters specified in the USP Monograph for Absorbable Surgical Sutures and other applicable requirements:
10
- Diameter, USP 39
- Needle Attachment, USP 39 ●
- Tensile Strength, USP 39 ●
- In vitro Breaking Strength Retention (BSR)
- Visual Inspection ●
- . Moisture content
- Sterility Testing, USP 39-NF34 ●
The study results demonstrated conformance to the specified acceptance criteria and supported the 5 year expiration date assignment for CARESORB® and CARESORB® RAPID sutures.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 Surgical Sutures are composed of the same material, have the same intended use and main technological characteristics as their respective predicate devices Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide Surgical Sutures.
Based on the results of completed performance testing inclusive of physical testing, biocompatibility testing and absorption profile, it can be concluded that CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are substantially equivalent in terms of safety and effectiveness to Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide respectively.