RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed

K161737 · Myco Medical · NEW · Mar 2, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161737
• Device Name: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed
• Applicant: Myco Medical
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

Device Story

REDIDIOX is a synthetic, absorbable, monofilament surgical suture composed of polydioxanone polyester. It is provided in dyed (D&C Violet) or undyed forms, in various lengths and diameters, with or without attached needles. The device is intended for single-use in soft tissue approximation by clinicians. It functions by providing mechanical support to tissues during the healing process, gradually losing strength over time as it is absorbed by the body (total absorption in 182 days). The suture is sterile, non-pyrogenic, and non-antigenic. It is used in clinical settings for surgical procedures.

Clinical Evidence

Bench testing only. Testing confirmed conformance to USP monographs for tensile strength, diameter, needle attachment, and extractable color. Biocompatibility testing performed per ISO 10993. Absorption profile and strength retention data provided (70% at 14 days, 50% at 28 days, 25% at 42 days).

Technological Characteristics

Synthetic monofilament polydioxanone (C4H6O3)n. Sterilized by EtO gas. Complies with USP requirements for absorbable surgical sutures (except diameter). Biocompatible per ISO 10993. Single-use.

Indications for Use

Indicated for soft tissue approximation, including ophthalmic surgery. Contraindicated for cardiovascular and neurological tissues.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PD SYNTH (K081001)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>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:<br>PD Synth | Comment |
|---------------|--------------|-------------------------------|---------|
| 510(k) Number | N/A | K081001 | |

## Summary of Technological Characteristics

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| Indications for Use | The REDIDIOX<br>Suture is used in | Indicated for use in | Identical |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | soft tissue<br>approximation,<br>including use in<br>ophthalmic<br>surgery, but not<br>for use in cardio<br>vascular and<br>neurological<br>tissues. | soft tissue<br>approximation,<br>including use in<br>ophthalmic<br>procedures, but not<br>for use in<br>cardiovascular and<br>neurological<br>procedures. | |
| Suture is a synthetic absorbable<br>surgical suture. It is a sterile<br>flexible monofilament thread,<br>composed of polydioxanone.<br>The sutures are inert,<br>noncollageneous and<br>nonantigenic. | Yes | Yes | Identical |
| Suture is dyed with D&C Violet<br>#2 with content below 0.1 wt%<br>being monofilament it is coated. | Yes | Yes | Identical |
| Offered in a variety of lengths<br>and a range of diameters with or<br>without various needles<br>attached. | Yes | Yes | Identical |
| Suture is supplied for single use<br>only | Yes | Yes | Identical |
| Suture is sterilized by EtO gas | Yes | Yes | Identical |
| Suture is packaged in the same<br>or equivalent manner, and has<br>the same equivalent labeling<br>claims as that of the predicate<br>device(s) including indications,<br>warnings, cautions and<br>precautions | Yes | Yes | Identical |
| Meets are exceeds the<br>performance requirements for<br>"Absorbable Surgical Suture" as<br>defined in the Official<br>Monograph of the USP<br>(exceptions diameter) | Yes | Yes | Identical |
| Meets the performance<br>requirements defined in the USP<br>for "Suture Length<br>Requirement" 95% of stated<br>label length | Yes | Yes | Identical |
| Meets the performance<br>requirements defined in the USP<br>current edition for sterility | Yes | Yes | Identical |
| Suture is biologically compatible<br>when tested as per ISO 10993 | Yes | Yes | Identical |
| Suture is tested and proved to<br>be non-toxic when tested as per<br>ISO 10993 for toxicity | Yes | Yes | Identical |
| Days Implantation | Approximate %<br>Original Strength<br>Remaining | | |
| 14 days | 70% | | Identical |
| 28 days | 50% | | Identical |
| 42 days | 25% | | Identical |

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# 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.