(252 days)
Not Found
No
The device description and performance studies focus solely on the material properties and physical performance of a surgical suture, with no mention of AI or ML capabilities.
No
The device is a suture, which is used for soft tissue approximation. While it is used in surgical procedures, it is a surgical tool/material and not a device that directly treats or prevents a disease or condition in the way a therapeutic device would (e.g., pain relief, drug delivery, or a diagnostic function). It assists in the healing process by holding tissues together.
No
Explanation: The device is described as a surgical suture used for soft tissue approximation. Its function is to hold tissues together, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a physical suture made from a polymer, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the REDIDIOX Suture is for "soft tissue approximation," which is a surgical procedure performed on the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) to provide information about a person's health.
- Device Description: The description details a surgical suture made of a specific polymer. This is a physical device used in surgery, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring analytes.
The REDIDIOX Suture is a medical device used in vivo (within the living body) for surgical purposes, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
Product codes
NEW
Device Description
The REDIDIOX is a (Polydioxanone) monofilament synthetic absorbable suture prepared from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3). Polydioxanone polymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. Based on absorption study it takes 182 days for total absorption. The monofilament material is available undyed and dyed. The dyed material is colored violet, dyed with D&C Violet. REDIDIOX sutures comply with USP requirements, except for diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, ophthalmic, not for use in cardiovascular and 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
Non-clinical laboratory testing was conducted to confirm that the REDIDIOX Suture conforms to USP monograph for absorbable sutures for tensile strength, diameter, needle attachment, extractable color, sterilization validation, shelf life, and biocompatibility. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003, and Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, Issued May 1, 1995.
Key Metrics
Days Implantation-14 days: Approximate % Original Strength Remaining-70%
Days Implantation-28 days: Approximate % Original Strength Remaining-50%
Days Implantation-42 days: Approximate % Original Strength Remaining-25%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Myco Medical c/o Mr. E. J. Smith Smith Assoicates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K161737
Trade/Device Name: Reli Redidiox Dyed, Reli Redidiox, Reli Redidiox Undyed Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: January 31, 2017 Received: February 1, 2017
Dear Mr. Smith:
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 (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.
1
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 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 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
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Indications for Use
510(k) Number (if known) K161737
Device Name REDIDIOX SUTURE
Indications for Use (Describe)
The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| SPONSOR | ||
|---|---|---|
| Company Name: | Myco Medical | |
| Company Address: | 158 Towerview Court | |
| Cary, North Carolina 27513 | ||
| Telephone: | 919-460-2535 | |
| Contact Person: | Sanjv Kumar | |
| Summary Prepared | February 27, 2017 | |
| Trade Name: | Redidiox™ REDIDIOX Monofilament Polydioxanone | |
| Absorbable Suture | ||
| Common/Usual Name: | Surgical Sutures | |
| Classification Name: | Absorbable polydioxanone surgical suture | |
| Product Code: | NEW | |
| Device Class: | Class II | |
| Regulation Number: | 21 CFR 878.4840 | |
| Predicate Device | ||
| Company | Product | 510(k) # |
| Sutures India Pvt Ltd | PD SYNTH | K081001 |
Device Description
The REDIDIOX is a (Polydioxanone) monofilament synthetic absorbable suture prepared from the polyester poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3). Polydioxanone polymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption. Based on absorption study it takes 182 days for total absorption. The monofilament material is available undyed and dyed. The dyed material is colored violet, dyed with D&C Violet. REDIDIOX sutures comply with USP requirements, except for diameter.
Indications for Use
The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardio vascular and neurological tissues.
| Parameters | Myco Medical | Predicate device:
PD Synth | Comment |
|---------------|--------------|-------------------------------|---------|
| 510(k) Number | N/A | K081001 | |
Summary of Technological Characteristics
4
| Indications for Use | The REDIDIOX
Suture is used in | Indicated for use in | Identical |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | soft tissue
approximation,
including use in
ophthalmic
surgery, but not
for use in cardio
vascular and
neurological
tissues. | soft tissue
approximation,
including use in
ophthalmic
procedures, but not
for use in
cardiovascular and
neurological
procedures. | |
| Suture is a synthetic absorbable
surgical suture. It is a sterile
flexible monofilament thread,
composed of polydioxanone.
The sutures are inert,
noncollageneous and
nonantigenic. | Yes | Yes | Identical |
| Suture is dyed with D&C Violet
#2 with content below 0.1 wt%
being monofilament it is coated. | Yes | Yes | Identical |
| Offered in a variety of lengths
and a range of diameters with or
without various needles
attached. | Yes | Yes | Identical |
| Suture is supplied for single use
only | Yes | Yes | Identical |
| Suture is sterilized by EtO gas | Yes | Yes | Identical |
| Suture is packaged in the same
or equivalent manner, and has
the same equivalent labeling
claims as that of the predicate
device(s) including indications,
warnings, cautions and
precautions | Yes | Yes | Identical |
| Meets are exceeds the
performance requirements for
"Absorbable Surgical Suture" as
defined in the Official
Monograph of the USP
(exceptions diameter) | Yes | Yes | Identical |
| Meets the performance
requirements defined in the USP
for "Suture Length
Requirement" 95% of stated
label length | Yes | Yes | Identical |
| Meets the performance
requirements defined in the USP
current edition for sterility | Yes | Yes | Identical |
| Suture is biologically compatible
when tested as per ISO 10993 | Yes | Yes | Identical |
| Suture is tested and proved to
be non-toxic when tested as per
ISO 10993 for toxicity | Yes | Yes | Identical |
| Days Implantation | Approximate %
Original Strength
Remaining | | |
| 14 days | 70% | | Identical |
| 28 days | 50% | | Identical |
| 42 days | 25% | | Identical |
5
Non Clinical Testing
Non-clinical laboratory testing was conducted to confirm that the REDIDIOX Suture conforms to USP monograph for absorbable sutures for tensile strength, diameter, needle attachment, extractable color, sterilization validation, shelf life, and biocompatibility. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003, and Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, Issued May 1, 1995
Substantial Equivalence Conclusion
The REDIDIOX Suture is substantially equivalent to the predicate in Indications for Use, operating principle, device design and material. The results of safety and efficacy testing demonstrates that the REDIDIOX Suture is substantially equivalent to the predicate device and raises no new issues of safety and effectiveness.