Athena Surgical RMUS System
Device Facts
| Record ID | K210087 |
|---|---|
| Device Name | Athena Surgical RMUS System |
| Applicant | Athena Surgical, LLC |
| Product Code | OTN · General, Plastic Surgery |
| Decision Date | Apr 12, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
System comprises sterile, single-use retropubic mid-urethral sling (RMUS) implant assembly and non-sterile, reusable handle assembly. Implant consists of blue polypropylene mesh (1.1cm x 46cm) with clear plastic sheath and stainless steel needles. Used in surgical setting by physicians; needles attach to handle assembly to position mesh via transvaginal retropubic approach. Mesh provides sub-urethral support to treat stress urinary incontinence. Device is mechanical; no software or algorithms involved.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing, including mechanical performance (tensile strength, elongation, stiffness, burst strength, dimensional analysis), sterilization validation (ISO 11135:2014), reprocessing validation, shelf-life testing, and biocompatibility (ISO 10993-1).
Technological Characteristics
Mesh: knitted extruded polypropylene filaments (0.63mm thick). Sheath: low-density polyethylene. Needles: stainless steel. Delivery: handle with detachable curved needle. Sterilization: EtO, SAL 10^-6. Biocompatibility: ISO 10993-1 compliant. Mechanical performance: tensile strength, elongation, stiffness, burst strength.
Indications for Use
Indicated for female patients with stress urinary incontinence caused by urethral hypermobility and/or intrinsic sphincter deficiency.
Regulatory Classification
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.
Predicate Devices
- Ethicon GYNECARE TVT EXACT™ (K132054)
Submission Summary (Full Text)
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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)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Athena Surgical. The word "ATHENA" is written in large, yellow, sans-serif font. Below the word "ATHENA" is the word "SURGICAL" written in a smaller, blue, sans-serif font.
**510(k) Summary**
[As Required by 21 CFR 807.92]
| (a)(1) Date Prepared: | | January 11, 2021 |
|---------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitted By: | Athena Surgical, LLC<br>6110 Blue Circle Drive, Suite 280<br>Minnetonka, MN 55343 |
| | Phone: | 612.888.9394 |
| | Contact: | Greg Slusser |
| | Prepared By: | Medavise, LLC<br>8725 Columbine Rd. #44952<br>Eden Prairie, MN 55344 |
| | Phone: | 612.405.4059 |
| (a)(2) Proprietary Name: | | Athena Surgical RMUS System |
| | Common Name: | Urinary sling |
| | Classification Regulation:<br>Class:<br>Product Code: | 21 CFR 878.3300 - Surgical Mesh<br>ll<br>OTN - Mesh, Surgical, Synthetic,<br>Urogynecologic, For Stress Urinary<br>Incontinence, Retropubic Or<br>Transobturator |
| (a)(3) Predicate Devices: | | |
| | Primary: | Ethicon GYNECARE TVT EXACT™ |
*No predicate has been subject to a design related recall.
### (a)(4) 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.
(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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Image /page/4/Picture/1 description: The image shows the logo for Athena Surgical. The word "ATHENA" is written in large, gold, sans-serif font. Below the word "ATHENA" and slightly to the left is the word "SURGICAL" in a smaller, sans-serif font.
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 and<br>Product Code | 21 CFR 878.3300 - OTN | Same |
| Intended Use | The Athena Surgical RMUS System is<br>intended to treat female stress urinary<br>incontinence. | Same |
| Indications | The Athena Surgical RMUS System is<br>indicated for use as a pubourethral sling<br>for treatment of female stress urinary<br>incontinence resulting from urethral<br>hypermobility and/or intrinsic sphincter<br>deficiency. | The GYNECARE TVT EXACT Continence<br>System is intended to be used as a pubo-<br>urethral sling for treatment of female<br>Stress Urinary Incontinence, resulting<br>from urethral hypermobility and/or<br>intrinsic sphincter deficiency. |
| Materials | Mesh - Polypropylene<br>Sheath - Low Density Polyethylene<br>Needle - Stainless Steel | Same |
| Delivery System<br>Design | 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 Strength<br>Elongation at Break<br>Stiffness 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:
i
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.
