(82 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical stimulation and neuromuscular reeducation, which are not inherently AI/ML technologies.
Yes
The device is intended for the "rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women," which is a therapeutic purpose.
No
The device description states its purpose is to provide electrical stimulation and neuromuscular reeducation for rehabilitation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "vaginal two electrode stimulation probe," which is a hardware component, not solely software.
Based on the provided information, the Athena Pelvic Muscle Trainer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Athena Pelvic Muscle Trainer Function: The description clearly states the device provides electrical stimulation and neuromuscular reeducation to the pelvic floor muscles within the body. It does not analyze samples taken from the body.
Therefore, the Athena Pelvic Muscle Trainer falls under the category of a therapeutic or rehabilitation device, not an IVD.
N/A
Intended Use / Indications for Use
The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
Product codes
KPI
Device Description
The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Guidates on the Collient and Organization of a 7-200 System (K960496), Athena Pelvic Muscic Trainer (K023905)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
0
Appendix F
510(k) Premarket Notification Summary of Safety and Effectiveness Information
Athena Pelvic Muscle Trainer II October 6, 2003
- Device Name 1. Trade Name: : Athena Pelvic Muscle Trainer H Common Names: : Athena Pelvic Muscle Trainer II Conunon Name: Stimulator, Electrical, Non-Implantable, for Incontinence
- Establishment Name & Registration Number: 2.
Name: Athena Feminine Technologies
Number: none
ર :
- Classification: 3. Title 21, Code of Federal Regulations, &Sec. 876.5320 ProCode: KPI
- Guidance Documents, Performance Standards and Special Controls: 4. At the present time, the following guidance documents are in effect for this device:
Guidance on the Content and Organization of a Premarket Notification. Guidates on the Collient and Organization of a 7-200 System (K960496), Athena Pelvic Muscic Trainer (K023905)
-
Applicant/Sponsor Name / Address: 6.
Athena Feminine Technologies 179 Moraga Way Orinda, CA 94563 (925) 254-6090 -
Company Contact: George Sarkis, CEO 7. Athena Feminine Technologies 179 Moraga Way Orinda, CA 94563 (925) 254-6090
-
Barbara Sarkis, CIO Submission Correspondent: 8. Athena Feminine Technologies 179 Moraga Way Orinda, CA 94563 (925) 254-6090
-
Description of the Device and Indications for Use: 9.
Description of the Device: The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operale one in escripted Description of the Device. The Atlena Perio Missic Trans 15 a raginal vide of the remote control and is activated upon removal from the cradle.
Indications for use: The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and Indications for use: The Allena Perior Musele Transitive is montales for the treatment of stress, urge and mixed urinary incontinence in women.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Ms. Barbara Sarkis Chief Information Officer Athena Feminine Technologies, Inc. 179 Moraga Way ORINDA CA 94563
Re: K033256
Trade/Device Name: Athena Pelvic Muscle Trainer II Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: 78 KPI Dated: October 6, 2003 Received: October 10, 2003
Dear Ms. Sarkis:
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 rcclassified 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.
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, I'DA 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and w you've ough.
The letter will and w you've of substantial equivalence of your device to a legally prematicated predicated in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at to your of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or Othphanos as ( ( notification" (21CFR Part 807.97) you may obtain. Other general by relective to premarked nonitions under the Act may be obtained from the Division of Small Internation on your respensional Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) NUMBER: K 03325 6
DEVICE NAME: Athena Pelvic Muscle Trainer II
INDICATIONS FOR USE:
The Athena Pelvic Muscle Trainer is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use | ________________ |
|---|---|
| ---------------------- | ------------------ |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, |
| and Radiological Devices |
| 510(k) Number | K033256 |
|---|---|
| --------------- | --------- |
510(k) Number __