(273 days)
External electrical neuromuscular stimulation using biphasic output is indicated as therapeutic adjunct for: prevention or retardation of muscle disuse atrophy; relaxation of muscle spasm; muscle reeducation; maintaining and increasing the range of motion; increasing local blood circulation and as immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.
The provided text describes a 510(k) premarket notification for a neuromuscular stimulator (BMLS03-3) and does not contain detailed acceptance criteria and a study proving the device meets those criteria in the way typically expected for performance claims of AI/ML or diagnostic devices.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as a set of quantified performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) for clinical or diagnostic outcomes.
The "acceptance criteria" here implicitly revolve around demonstrating functional equivalence based on device specifications to the predicate devices.
Acceptance Criteria (Implied from Substantial Equivalence Claim):
- Output Pulse Strength Equivalence: The BMLS03-3's output pulse strength must be equivalent to that of the BMLS03-1 predicate device.
- Other Device Parameters: The BMLS03-3 must be identical to the BMLS02-5 predicate device in all other aspects (e.g., waveform, pulse rate, pulse width, intensity range, modes, display).
Reported Device Performance (from "Comparison to Predicate Device"):
| Specific Acceptance Criteria | Reported Device Performance |
|---|---|
| Output Pulse Strength (relative to BMLS03-1) | "The output pulse strength of the BMLS03-3 is equivalent to the predicate (BioMedical Life Systems, Inc.) BMLS03-1." |
| Identity to BMLS02-5 (excluding output pulse strength) | "The BMLS03-3 is identical to the predicate (BioMedical Life Systems, Inc.) BMLS02-5 device in every way except for output pulse strength." |
| Clinical Effectiveness for Listed Indications (e.g., muscle reeducation, disuse atrophy) | Not applicable. No clinical studies were performed. The device's clinical effectiveness is presumed based on the predicate device's established use. |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical "test set" in the context of patient data was used. The testing was limited to "bench testing" of the physical device.
- Data Provenance: Not applicable, as no human data was used for testing. The "bench testing" would involve laboratory measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no ground truth for a test set established by experts, as no clinical or diagnostic performance was being evaluated. The equivalence was determined through engineering bench tests.
4. Adjudication method for the test set
- Not applicable. No adjudication method was used, as there was no test set requiring expert review or consensus.
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
- No. This is a medical device (neuromuscular stimulator), not an AI/ML or diagnostic imaging device. Therefore, MRMC studies and "human readers" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. Bench testing evaluated the device's physical output characteristics.
7. The type of ground truth used
- The "ground truth" for the equivalence claim was based on measurements from bench testing comparing the physical output characteristics (specifically pulse strength) of the BMLS03-3 directly against the BMLS03-1 predicate device, and other parameters against the BMLS02-5 predicate device. It's not a clinical "ground truth" like pathology or outcomes data.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that employs a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
Summary of the Study:
The "study" to prove the device meets acceptance criteria was non-clinical bench testing.
- Methodology: The BMLS03-3 was directly compared to two predicate devices:
- BMLS02-5: The BMLS03-3 was found to be "identical in every way" except for output pulse strength.
- BMLS03-1: The output pulse strength of the BMLS03-3 was determined to be "equivalent" through bench testing.
- Purpose: To demonstrate that the new device (BMLS03-3) is substantially equivalent to legally marketed predicate devices, thereby allowing it to be cleared for market without requiring new clinical trials.
- Conclusion: Based on the bench testing, the FDA determined the device to be substantially equivalent to the predicate devices for the stated indications for use. No clinical trials were deemed necessary, as explicitly stated in the document ("Clinical Testing: Not applicable.").
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K033i74
JUN 3 0 2004
510(k) SUMMARY (As required by 21 CFR 807.93)
(1) GENERAL
Submitter Name: Address:
| Phone: |
|---|
| Fax: |
| Contact: |
| Date Prepared: |
BioMedical Life Systems, Inc. P.O. Box 1360 Vista, CA 92085 760-727-5600 760-727-4220 Richard Saxon 26 September 2003
(2) DEVICE
Name: Trade or Proprietary Name: Common or Usual Name: Classification Name:
BMLS03-3 Neuromuscular Stimulator 21 CFR 890.5850 Powered Muscle Stimulator, Class II IPF
Product Code:
(3) PREDICATE DEVICES
Trade or Proprietary Name: Common or Usual Name: Classification Name:
Product Code:
Trade or Proprietary Name: Common or Usual Name: Classification Name:
BMLS02-5 Neuromuscular Stimulator 21 CFR 890 5850 Powered Muscle Stimulator, Class II IPF
BMLS03-1 Neuromuscular Stimulator 21 CFR 890.5850 Powered Muscle Stimulator, Class II IPF
Product Code:
(4) DEVICE DESCRIPTION
The BMLS03-3 is a portable, battery-powered four channel neuromuscular stimulator. The output waveform can be set to symmetrical or asymmetrical biphasic rectangular. The pulse rate range is 1-120 Hz. The pulse width range is 50-400 microseconds. The output intensity range is 0-100 milliamps. It can be set to constant, cycled, or reciprocating modes, and has several preprogrammed modes. All device functions and status are displayed on a graphic LCD.
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(5) INTENDED USE
The BMLS03-3 is recommended for use for the following conditions:
- Prevention or retardation of muscle disuse atrophy; .
- Relaxation of muscle spasm; .
- Muscle reeducation; ●
- Maintaining and increasing the range of motion; .
- Increasing local blood circulation .
- Immediate postsurgical stimulation of calf muscles to prevent . venous thrombosis.
(6) COMPARISON TO PREDICATE DEVICE
| Non-clinical Testing: | The BMLS03-3 is identical to the predicate (BioMedical Life Systems, Inc.) BMLS02-5 device in every way except for output pulse strength. The output pulse strength of the BMLS03-3 is equivalent to the predicate (BioMedical Life Systems, Inc.) BMLS03-1. This equivalency was determined through bench testing. |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Clinical Testing:
Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. 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
JUN 3 0 2004
Mr. Gary Busset BioMedical Life Systems, Inc. P.O. Box 1360 Vista, California 92085-1360
Re: K033174
Trade/Device Name: Model BMLS03-3 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: June 4, 2004 Received: June 7, 2004
Dear Mr. Busset:
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, 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 such 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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Page 2 - Mr. Gary Busset
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 (301) 594-4659. 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 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,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
| 510(k) Number (if known): | K033174 |
|---|---|
| Device Name: | (EMS) Electrical Neuromuscular StimulatorFor Muscle Reeducation - Class IIModel BMLS03-3 |
| Indications for Use: | External electrical neuromuscular stimulation using biphasic output isindicated as therapeutic adjunct for: prevention or retardation of muscledisuse atrophy; relaxation of muscle spasm; muscle reeducation;maintaining and increasing the range of motion; increasing local bloodcirculation and as immediate postsurgical stimulation of calf muscles toprevent venous thrombosis. |
Prescription Use X
(Part 21 CFR 801, Subpart D)
AND/OR
Over-The-Counter Use (21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).