The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The Athena Surgical RMUS System consists of a sterile, single-use Retropubic Mid-Urethral Sling (RMUS) Implant Assembly and a non-sterile, reusable RMUS Handle Assembly. Each RMUS Implant Assembly contains one blue polypropylene mesh sling implant (1.1cm x 46cm), covered by a non-implantable clear plastic sheath and attached on each end to nonimplantable stainless steel needles. The mesh implant is constructed of knitted filaments of extruded polypropylene strands and is approximately 0.63mm thick. The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.

AI/ML Overview

This FDA 510(k) summary is for a medical device called the Athena Surgical RMUS System, a pubourethral sling for treating female stress urinary incontinence.

Here's an analysis of the acceptance criteria and the study information, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving individual clinical effectiveness based on a completely novel set of performance criteria. Therefore, many of the typical "acceptance criteria" for clinical efficacy studies (like sensitivity, specificity, accuracy) are not explicitly defined or measured in this type of submission. Instead, the "acceptance criteria" are primarily related to comparison with the predicate device and the results of non-clinical (bench) testing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, for a 510(k) submission, explicit "acceptance criteria" of the type one would see in a clinical trial for a new drug or novel device (e.g., "sensitivity must be >90%") are not typically provided. Instead, the criteria relate to demonstrating similarity to a predicate device and meeting relevant safety and performance standards through non-clinical testing.

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (Summary from Non-Clinical Testing)
Substantial Equivalence to Predicate Device	Device found to be substantially equivalent to the Ethicon GYNECARE TVT EXACT™ based on similarities in intended use, design, materials, sterilization, and performance.
Mechanical Performance (Mesh)	Successful evaluation of: Ultimate Tensile Strength, Elongation at Break, Stiffness Bending Length, Burst Strength, Dimensional Analysis (monofilament diameter, device width, pore size, mesh thickness, mesh density, mesh weave characteristics). (Specific values not provided in this summary, but implied to meet standards).
Sterilization Validation	Validated per ISO 11135:2014 (Ethylene Oxide sterilization, sterility assurance level (SAL) 10-6, single-use).
Reprocessing Validation (Reusable Instruments)	Successfully validated for reusable instruments.
Shelf Life Testing	Evaluated for packaging integrity and mechanical performance. (Implied to meet shelf-life requirements).
Biocompatibility (Implant Sheath & Needles - <24h contact)	Successfully passed: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity (per ISO 10993-1).
Biocompatibility (Mesh - Permanent Implant >30 days contact)	Successfully passed: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Implantation, Subacute toxicity, Subchronic toxicity, Genotoxicity, and Carcinogenicity (through chemical characterization and toxicological risk assessment) (per ISO 10993-1).
Pyrogenicity Testing	Successfully passed Pyrogenicity testing.
No New Questions of Safety/Efficacy	"The technological characteristics do not raise any new questions of safety and efficacy."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k) summary. No clinical test set (i.e., patient data) was used for evaluation. The safety and effectiveness were demonstrated through non-clinical (bench) testing and comparison to a predicate device.
Data Provenance: Not applicable. The "study" for this submission was primarily non-clinical bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There was no clinical test set requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." The focus was on non-clinical testing and comparison to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical surgical implant and its associated delivery system, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by engineering and biological standards and specifications. For instance, the ground truth for mechanical properties would be defined by established ASTM or ISO test methods and acceptance limits (e.g., "ultimate tensile strength must be X MPa"), and for biocompatibility, it would be the absence of toxic reactions as determined by ISO 10993 standards.
For the overall submission, the "ground truth" for "acceptability" is the demonstration of substantial equivalence to a legally marketed predicate device (Ethicon GYNECARE TVT EXACT™), meaning it shares the same intended use, fundamental technological characteristics, and performs as safely and effectively as the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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April 9, 2021

Athena Surgical, LLC % Kellen Hills Biomedical Engineer Medavise Consulting 8725 Columbine Rd. #44952 Eden Prairie, MN 55344

Re: K210087

Trade/Device Name: Athena Surgical RMUS System Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTN Dated: January 11, 2021 Received: January 13, 2021

Dear Kellen Hills:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sharon M. Andrews -S

For

Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210087

Device Name Athena Surgical RMUS System

Indications for Use (Describe)

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
[As Required by 21 CFR 807.92]

(a)(1) Date Prepared:		January 11, 2021
	Submitted By:	Athena Surgical, LLC6110 Blue Circle Drive, Suite 280Minnetonka, MN 55343
	Phone:	612.888.9394
	Contact:	Greg Slusser
	Prepared By:	Medavise, LLC8725 Columbine Rd. #44952Eden Prairie, MN 55344
	Phone:	612.405.4059
(a)(2) Proprietary Name:		Athena Surgical RMUS System
	Common Name:	Urinary sling
	Classification Regulation:Class:Product Code:	21 CFR 878.3300 - Surgical MeshllOTN - Mesh, Surgical, Synthetic,Urogynecologic, For Stress UrinaryIncontinence, Retropubic OrTransobturator
(a)(3) Predicate Devices:
	Primary:	Ethicon GYNECARE TVT EXACT™

*No predicate has been subject to a design related recall.

(a)(4) Device Description:

(K132054);

The Athena Surgical RMUS Implant Assembly is designed to be used with the non-sterile, reusable Athena Surgical RMUS Handle Assembly, which consists of two parts: the Handle Body and the Handle Insert. The stainless steel needles from the RMUS Implant Assembly

6110 Blue Circle Drive | Suite 280 | Minnetonka, MN 55343

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are designed to fit inside the RMUS Handle Assembly, which is used to position the implantable mesh in the patient from a vaginal incision up through the abdominal wall.

The purpose of this submission is to gain initial marketing authorization in the United States.

(a)(5) Indications for Use:
The Athena Surgical RMUS System is indicated for use as a pubourethral sling for treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
(a)(6) Comparison of Technological Characteristics:
The Athena Surgical RMUS System is substantially equivalent to the identified predicate based on similarities in intended use, design, materials, sterilization and performance. The technological characteristics do not raise any new questions of safety and efficacy.

	Subject Athena Surgical RMUS System	Predicate Ethicon GYNECARE TVT™
510(k)	TBD	K132054
Regulation andProduct Code	21 CFR 878.3300 - OTN	Same
Intended Use	The Athena Surgical RMUS System isintended to treat female stress urinaryincontinence.	Same
Indications	The Athena Surgical RMUS System isindicated for use as a pubourethral slingfor treatment of female stress urinaryincontinence resulting from urethralhypermobility and/or intrinsic sphincterdeficiency.	The GYNECARE TVT EXACT ContinenceSystem is intended to be used as a pubo-urethral sling for treatment of femaleStress Urinary Incontinence, resultingfrom urethral hypermobility and/orintrinsic sphincter deficiency.
Materials	Mesh - PolypropyleneSheath - Low Density PolyethyleneNeedle - Stainless Steel	Same
Delivery SystemDesign	Handle with detachable curved Needle	Handle with fixed curved Needle
Entry Method	Transvaginal Retropubic	Same
Sterility	EtO, SAL 10-6, single-use	Same
Performance	Ultimate Tensile StrengthElongation at BreakStiffness Bending Length	Same

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K210087 Page 3 of 3

Image /page/5/Picture/1 description: The image shows the word "ATHENA" in a stylized, sans-serif font. The letters are a golden color. Below the word "ATHENA" is the word "SURGICAL" in a smaller, sans-serif font. The word "SURGICAL" is a light blue color.

(b)(1) Non-clinical testing:

The subject device was successfully evaluated according to the following:

Mechanical performance testing
- Ultimate tensile strength .
- . Elongation at break
- . Stiffness bending strength
- . Burst strength
- . Dimensional analysis (monofilament diameter, device width, pore size, mesh thickness, mesh density, mesh weave characteristics)
트 Sterilization validation per ISO 11135:2014
Reprocessing validation for reusable instrumentation ■
I Shelf life testing evaluating packaging integrity and mechanical performance
트 Biocompatibility per ISO 10993-1
- Implant Sheath and Needles (external communicating device contacting tissue for less than 24 . hours)
  - o Cytotoxicity
  - Sensitization O
  - Irritation O
  - Acute systemic toxicity O
- Mesh (permanent implant contacting tissue for greater than 30 days) ●
  - Cytotoxicity O
  - Sensitization O
  - Irritation O
  - Acute systemic toxicity O
  - Implantation O
  - Subacute toxicity, subchronic toxicity, genotoxicity, and carcinogenicity through O chemical characterization and toxicological risk assessment
. Pyrogenicity testing

(b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

(b)(3) Conclusions:

Based on the information provided in this premarket notification the subject Athena Surgical RMUS System demonstrates substantial equivalence to the identified predicate device.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.