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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the REDIDIOX Suture:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly present a dedicated "acceptance criteria" table with corresponding "reported device performance" in a quantitative format for all aspects. Instead, it relies on demonstrating compliance with established standards (USP, ISO) and equivalence to a predicate device. However, we can extract the key performance parameters and their reported outcomes:

Acceptance Criteria / Performance Parameter	Reported Device Performance / Compliance
Indications for Use: Soft tissue approximation, including ophthalmic surgery, but not for cardiovascular and neurological tissues.	Identical to predicate device.
Material Composition: Synthetic absorbable, sterile, flexible monofilament thread, composed of polydioxanone. Inert, noncollageneous, nonantigenic.	Yes (Identical)
Dye: Dyed with D&C Violet #2, content below 0.1 wt%, monofilament, not coated.	Yes (Identical). The text states "being monofilament it is coated" for the predicate, but "not coated" in the description, suggesting a minor discrepancy or an oversight in the table. However, the "Identical" column usually indicates full agreement. Given the overall context, the dye presence and concentration are key.
Availability: Offered in variety of lengths and range of diameters with or without various needles attached.	Yes (Identical)
Single Use: Supplied for single use only.	Yes (Identical)
Sterilization: Sterilized by EtO gas.	Yes (Identical)
Packaging & Labeling: Same or equivalent manner and labeling claims as predicate device (indications, warnings, cautions, precautions).	Yes (Identical)
Performance Requirements (USP "Absorbable Surgical Suture"): Meets or exceeds requirements (exceptions diameter).	Yes (Identical)
Performance Requirements (USP "Suture Length Requirement"): 95% of stated label length.	Yes (Identical)
Performance Requirements (USP Sterility): Meets requirements.	Yes (Identical)
Biocompatibility: Biologically compatible per ISO 10993.	Yes (Identical)
Toxicity: Non-toxic per ISO 10993.	Yes (Identical)
Absorbability/Strength Retention:
- 14 days Implantation	70% Approximate Original Strength Remaining (Identical to predicate)
- 28 days Implantation	50% Approximate Original Strength Remaining (Identical to predicate)
- 42 days Implantation	25% Approximate Original Strength Remaining (Identical to predicate)
Total Absorption Time	182 days for total absorption (mentioned in Device Description). This is stated as a characteristic of the polydioxanone polymer.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a clinical trial or a specific patient data set. The evaluation performed is non-clinical laboratory testing. Therefore, there is no information on sample size and data provenance related to patient data. The "test set" for this device would refer to the physical suture samples subjected to various laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the non-clinical laboratory testing described. "Ground truth" established by experts is typically relevant for medical imaging or diagnostic AI devices where human interpretation is involved. For a surgical suture, compliance is determined by laboratory measurements against predefined standards (USP, ISO).

4. Adjudication method for the test set

This is not applicable as the study involves non-clinical laboratory testing against established specifications rather than expert interpretation or a diagnostic assessment requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a surgical suture, not an AI-assisted diagnostic or prognostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a surgical suture, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the REDIDIOX Suture testing is based on established regulatory and industry standards and specifications:

USP Monograph for Absorbable Sutures: This defines the requirements for tensile strength, diameter, needle attachment, suture length, and sterility.
ISO 10993 (Biological Evaluation of Medical Devices Part 1): This standard dictates the requirements for biocompatibility and toxicity testing.
Predicate Device Characteristics: The performance and characteristics of the legally marketed predicate device (PD SYNTH, K081001) serve as a comparative "ground truth" to demonstrate substantial equivalence, particularly for parameters like strength retention and indications for use.

8. The sample size for the training set

This is not applicable. As this is a 510(k) submission for a surgical suture based on substantial equivalence and non-clinical testing, there is no mention of a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set involved for this type of device submission.

Summary

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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.

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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 (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 PolydioxanoneAbsorbable 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

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

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Indications for Use	The REDIDIOXSuture is used in	Indicated for use in	Identical
	soft tissueapproximation,including use inophthalmicsurgery, but notfor use in cardiovascular andneurologicaltissues.	soft tissueapproximation,including use inophthalmicprocedures, but notfor use incardiovascular andneurologicalprocedures.
Suture is a synthetic absorbablesurgical suture. It is a sterileflexible monofilament thread,composed of polydioxanone.The sutures are inert,noncollageneous andnonantigenic.	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 lengthsand a range of diameters with orwithout various needlesattached.	Yes	Yes	Identical
Suture is supplied for single useonly	Yes	Yes	Identical
Suture is sterilized by EtO gas	Yes	Yes	Identical
Suture is packaged in the sameor equivalent manner, and hasthe same equivalent labelingclaims as that of the predicatedevice(s) including indications,warnings, cautions andprecautions	Yes	Yes	Identical
Meets are exceeds theperformance requirements for"Absorbable Surgical Suture" asdefined in the OfficialMonograph of the USP(exceptions diameter)	Yes	Yes	Identical
Meets the performancerequirements defined in the USPfor "Suture LengthRequirement" 95% of statedlabel length	Yes	Yes	Identical
Meets the performancerequirements defined in the USPcurrent edition for sterility	Yes	Yes	Identical
Suture is biologically compatiblewhen tested as per ISO 10993	Yes	Yes	Identical
Suture is tested and proved tobe non-toxic when tested as perISO 10993 for toxicity	Yes	Yes	Identical
Days Implantation	Approximate %Original StrengthRemaining
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.

Regulation Number and Section

§ 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.