(159 days)
Not Found
No
The summary describes a device that uses electrical stimulation and neuromuscular reeducation via a probe and remote control. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the hardware and basic functionality.
Yes
The device is intended for the rehabilitation of weak pelvic floor muscles to treat urinary incontinence, which is a therapeutic purpose.
No
The device is intended to provide electrical stimulation and neuromuscular reeducation for rehabilitation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it includes a vaginal two electrode stimulation probe and a FM remote control device, which are hardware components.
Based on the provided information, the Athena Pelvic Muscle Trainer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Athena Pelvic Muscle Trainer Function: The description clearly states that the device provides electrical stimulation and neuromuscular reeducation to the pelvic floor muscles using a vaginal probe. This is a direct interaction with the body for therapeutic purposes, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Athena Pelvic Muscle Trainer falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
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 operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic floor muscles (Vaginal)
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)
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 V
510(k) Premarket Notification ummary of Safety and Effectiveness Information
Athena Pelvic Muscle Trainer April 15, 2003
- 】. Device Name Trade Name: : Athena Pelvic Muscle Trainer Common Names: : Athena Pelvic Muscle Trainer Classification Name: Stimulator, Electrical, Non-Implantable, for Incontinence
-
- Establishment Name & Registration Number:
Name: Athena Feminine Technologies
Number: none
- Classification: 3. Title 21, Code of Federal Regulations, §Sec. 876.5320 ProCode: KPI
- Guidance Documents, Performance Standards and Special Controls: ব . At the present time, the following guidance documents are in effect for this device:
Guidance on the Content and Organization of a Premarket Notification.
- Equivalent Device(s): Utah Medical, Liberty PFS-200 System (K960496), Pathway CTS 2000 (K001515) న్. Hollister, Microgyn n (K963222)
-
- Applicant/Sponsor Name / Address: Athena Feminine Technologies _179 Moraga Way Orinda, CA 94563 (925) 254-6090
-
- Company Contact: George Sarkis, CEO Athena Feminine Technologies --179 Moraga Way Orinda, CA 94563 (925) 254-6090
-
- Submission Correspondent: Barbara Sarkis, CIO Athena Feminine Technologies 179 Moraga Way Orinda, CA 94563 (925) 254-6090
-
- Description of the Device and Indications for Use:
Description of the Device: The Athena Pelvic Muscle Trainer is a vaginal two electrode stimulation probe operated through a FM remote control device. The probe is stored in an activator box that turns the probe on automatically when the probe is removed from the box.
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.
1
APPENDIX III
Kc23905
| | Athena Pelvic
Muscle Trainer | Pathway CTS
2000 K001515¹ | Liberty PFS-200
System
K 960496 | InCare
Microgyn II
K963222 |
|----------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------|-----------------------------------------|
| Intended Use | Treatment of urinary
incontinence | Treatment of urinary
incontinence | Treatment of urinary
incontinence | Treatment of
urinary
incontinence |
| Programmable Features | Intensity | Intensity, Session
length | Channel, Intensity,
Continuous-Intermittent | Intensity |
| Channel Switch | Yes | Yes | Yes | No |
| Intensity Adjustment | Yes | Yes | Yes | yes |
| Duty Cycle of Stimulation | 2.5 sec stim / 2.5 sec
rest | 2 sec stim/1 sec rest | 5 sec stim/ 10 rest | 2 sec stim /4sec rest |
| Duration | 15 minutes | 0-30 minutes | 30 minutes | 15 minutes |
| Power Source | (Probe) 1 3.6 volt
lithium battery
(Remote) 3 AAA
alkaline batteries | Unknown | (2) 3 volt lithium
batteries | 9V alkaline |
| Treatment Protocol | 15 min/twice day | Set by physician | 15 min/twice day | 15 min/twice day |
| Mode of Operation | Intermittent | Intermittent | Intermittent/Continuous | Intermittent |
| Ingress Protection rating | IP67 – Protected from
Dust and liquid
ingress | Unknown | IPXO-no protection | Unknown |
| Output Current | 0 – 70 mA | 0-100 mA | 0-65 mA | Unknown |
| Pulse Width | $200 \mu S$ | $300 \mu s$ | $300 \mu s$ | $50-300 \mu s$ |
| Output Type | Constant voltage over
range of
100 to 1000 Ohms | Constant current over
unknown range. | Constant current over
range of 100 to 1000
Ohms | Unknown |
| Output Isolation
between Electrodes | $>10^8$ Ohms | Unknown | $>10^8$ Ohms | $>10^{12}$ |
| Number of Electrodes | 2 stimulators | Unknown | 2 stimulators | 4 stimulators |
| Usage Conditions | Reusable-single
patient use | Reusable-single
patient use | Reusable-single patient
use | Reusable-single
patient use |
| Electrode Orientation | Circular | Circular | Circular | Circular |
| Probe Length | 3.3 in. nominal | 2.9 in nominal | 2.8 in. nominal | 4.5 in. nominal |
| Probe Diameter | .99 in. nominal | .70 in. nominal | .95 in. nominal | 1 in. nominal |
| Electrode material | Stainless steel | Unknown | Stainless steel | Metal |
| Device Connection | RF Remote | Attached cord | Attached cord | Attached cord |
| Electrode Placement | Vaginal | Vaginal | Vaginal | Vaginal |
| Waveform Type | Square | Square | Square | Square |
| Waveform Shape | Asymmetrical | Asymmetrical | Symmetrical | Symmetrical |
| Frequency | 12.5Hz/50 Hz | 12.5Hz/50/100/200Hz | 12.5Hz/50 Hz | 10-400 Hz |
..e data for the Pathway CTS2000 Pelvic Floor Training System was obtained from their pre-market notification to include lditional functionality. In this report a number of the specifications were not given and as a result the nation in the table.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2003
Ms. Barbara Sarkis Chief Information Officer Athena Feminine Technologies, Inc. 179 Moraga Way ORINDA CA 94563
Re: K023905
Trade/Device Name: Athena Pelvic Muscle Trainer (PMT) Regulation Number: 21 CFR $876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: 78 KPI Dated: March 3, 2003 Received: March 4, 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 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. Iisting 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, 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at one 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and 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
Page 2
4
Page 1 of 1
510(k) NUMBER: K023905
Athena Pelvic Muscle Trainer DEVICE NAME:
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)
Over-The-Counter Use (Optional format 1-2-96)
David H. Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal.
OR
Radiological Devices
510(k) Number K023905