(159 days)
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.
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.
The provided text is a 510(k) Premarket Notification for the Athena Pelvic Muscle Trainer. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a standalone study with acceptance criteria and detailed performance metrics of the device itself. Therefore, many of the requested details about a study and its results cannot be fully extracted.
Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the context of a performance study for the Athena Pelvic Muscle Trainer. Instead, it compares the device's technical specifications to those of legally marketed predicate devices to establish substantial equivalence.
| Feature | Athena Pelvic Muscle Trainer (Reported Performance - as described in 510(k)) | Predicate Devices (Reference for Substantial Equivalence) |
|---|---|---|
| Intended Use | Treatment of urinary incontinence | Treatment of urinary incontinence (for all listed predicates) |
| Programmable Features | Intensity | Intensity, Session length (Pathway CTS 2000); Channel, Intensity, Continuous-Intermittent (Liberty PFS-200); Intensity (InCare Microgyn II) |
| Channel Switch | Yes | Yes (Pathway CTS 2000, Liberty PFS-200); No (InCare Microgyn II) |
| Intensity Adj. | Yes | Yes (for all listed predicates) |
| Duty Cycle | 2.5 sec stim / 2.5 sec rest | 2 sec stim/1 sec rest (Pathway CTS 2000); 5 sec stim/ 10 rest (Liberty PFS-200); 2 sec stim /4sec rest (InCare Microgyn II) |
| Duration | 15 minutes | 0-30 minutes (Pathway CTS 2000); 30 minutes (Liberty PFS-200); 15 minutes (InCare Microgyn II) |
| Power Source | (Probe) 1 3.6 volt lithium battery (Remote) 3 AAA alkaline batteries | Unknown (Pathway CTS 2000); (2) 3 volt lithium batteries (Liberty PFS-200); 9V alkaline (InCare Microgyn II) |
| Treatment Protocol | 15 min/twice day | Set by physician (Pathway CTS 2000); 15 min/twice day (Liberty PFS-200, InCare Microgyn II) |
| Mode of Operation | Intermittent | Intermittent (Pathway CTS 2000, Liberty PFS-200, InCare Microgyn II); Continuous (Liberty PFS-200) |
| Ingress Protection | IP67 – Protected from Dust and liquid ingress | Unknown (Pathway CTS 2000); IPXO-no protection (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Output Current | 0 – 70 mA | 0-100 mA (Pathway CTS 2000); 0-65 mA (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Pulse Width | $200 \mu S$ | $300 \mu s$ (Pathway CTS 2000); $300 \mu s$ (Liberty PFS-200); $50-300 \mu s$ (InCare Microgyn II) |
| Output Type | Constant voltage over range of 100 to 1000 Ohms | Constant current over unknown range (Pathway CTS 2000); Constant current over range of 100 to 1000 Ohms (Liberty PFS-200); Unknown (InCare Microgyn II) |
| Output Isolation | $>10^8$ Ohms | Unknown (Pathway CTS 2000); $>10^8$ Ohms (Liberty PFS-200); $>10^{12}$ (InCare Microgyn II) |
| Number of Electrodes | 2 stimulators | Unknown (Pathway CTS 2000); 2 stimulators (Liberty PFS-200); 4 stimulators (InCare Microgyn II) |
| Usage Conditions | Reusable-single patient use | Reusable-single patient use (for all listed predicates) |
| Electrode Orientation | Circular | Circular (for all listed predicates) |
| Probe Length | 3.3 in. nominal | 2.9 in nominal (Pathway CTS 2000); 2.8 in. nominal (Liberty PFS-200); 4.5 in. nominal (InCare Microgyn II) |
| Probe Diameter | .99 in. nominal | .70 in. nominal (Pathway CTS 2000); .95 in. nominal (Liberty PFS-200); 1 in. nominal (InCare Microgyn II) |
| Electrode material | Stainless steel | Unknown (Pathway CTS 2000); Stainless steel (Liberty PFS-200); Metal (InCare Microgyn II) |
| Device Connection | RF Remote | Attached cord (for all listed predicates) |
| Electrode Placement | Vaginal | Vaginal (for all listed predicates) |
| Waveform Type | Square | Square (for all listed predicates) |
| Waveform Shape | Asymmetrical | Asymmetrical (Pathway CTS 2000); Symmetrical (Liberty PFS-200, InCare Microgyn II) |
| Frequency | 12.5Hz/50 Hz | 12.5Hz/50/100/200Hz (Pathway CTS 2000); 12.5Hz/50 Hz (Liberty PFS-200); 10-400 Hz (InCare Microgyn II) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical performance study with a test set. This 510(k) is based on demonstrating substantial equivalence through comparison of technical specifications and intended use to predicate devices. No patient data or clinical study results for the Athena Pelvic Muscle Trainer are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study involving a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study involving a test set is described.
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
Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an electrical stimulator, not an algorithm, and its performance is assessed against predicate devices' technical specifications, not by an algorithm's standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study with defined ground truth is described. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior clearance, to which the new device claims substantial equivalence.
8. The sample size for the training set
Not applicable, as no AI model or training set is mentioned for this device.
9. How the ground truth for the training set was established
Not applicable, as no AI model or training set is mentioned for this device.
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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.
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APPENDIX III
Kc23905
| Athena PelvicMuscle Trainer | Pathway CTS2000 K001515¹ | Liberty PFS-200SystemK 960496 | InCareMicrogyn IIK963222 | |
|---|---|---|---|---|
| Intended Use | Treatment of urinaryincontinence | Treatment of urinaryincontinence | Treatment of urinaryincontinence | Treatment ofurinaryincontinence |
| Programmable Features | Intensity | Intensity, Sessionlength | 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 secrest | 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 voltlithium battery(Remote) 3 AAAalkaline batteries | Unknown | (2) 3 volt lithiumbatteries | 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 fromDust and liquidingress | 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 overrange of100 to 1000 Ohms | Constant current overunknown range. | Constant current overrange of 100 to 1000Ohms | Unknown |
| Output Isolationbetween Electrodes | $>10^8$ Ohms | Unknown | $>10^8$ Ohms | $>10^{12}$ |
| Number of Electrodes | 2 stimulators | Unknown | 2 stimulators | 4 stimulators |
| Usage Conditions | Reusable-singlepatient use | Reusable-singlepatient use | Reusable-single patientuse | Reusable-singlepatient 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.
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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.
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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
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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
§ 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).