(108 days)
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.
The Ortho Dx Neuromuscular Stimulator, Model 6700S, received a 510(k) clearance based on substantial equivalence to existing predicate devices rather than a study against a pre-defined acceptance criteria.
The submission focuses on verifying that the technical performance of the device matches or is identical to the operating parameters of the predicate devices. It does not present a clinical study with acceptance criteria for device performance in treating medical conditions.
Here's a breakdown of the information based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Output Waveform | Within/Identical to predicate devices (symmetric biphasic & high volt pulsed direct current) | "identical to the Mentor Neuromuscular II (NM III™), Model 6800S" and "identical to the GV II™ Model 9700" |
| Amplitude | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Pulse Width | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Pulse Rate | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Treatment Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Off Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Ramp Up Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Ramp Down Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Safety Considerations | No additional safety considerations compared to predicate devices | "proposes no additional safety considerations than the legally marketed predicate devices" |
| Power Supply (Line Powered Repac10) | UL approved | "The Line Powered Repac10 employees a UL approved power supply" |
2. Sample Size Used for the Test Set and Data Provenance
The document describes engineering verification testing focusing on the device's technical specifications, not a test set for clinical performance. Therefore, there is no "sample size" in the context of patient data. The testing involved measurements of the device's output parameters. The data provenance is internal engineering testing conducted at room temperature (72°C) and 50% relative humidity using a calibrated 5V power supply and calibrated measurement equipment. This is a form of prospective testing, as it's performed on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the engineering tests was established by comparison to the technical specifications of the predicate devices and the operator's manual. There were no human experts involved in establishing a "ground truth" for clinical performance, as this was not a clinical study.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication. The verification of technical parameters was based on direct measurement and comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission is for a medical device (neuromuscular stimulator), not an AI-assisted diagnostic or imaging device where such studies are common. The clearance is based on technological equivalence, not clinical superiority or human reader improvement.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone performance study in the context of an algorithm or AI was not performed. This device is a physical medical stimulator, not software with an algorithm. The "standalone" performance verification relates to its electrical output parameters.
7. Type of Ground Truth Used
The "ground truth" for the engineering verification was essentially:
- Predicate Device Specifications: The technical parameters (waveform, amplitude, pulse width, etc.) of the previously cleared predicate devices (Mentor Neuromuscular II, GV II, and TRI-STIM).
- Operator's Manual Technical Requirements: The device's own specified operating parameters.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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510(k) Summary
Ortho D. Neuromuscular Stimulator
Model 6700S
Product:
Ortho Dx Neuromuscular Stimulator, Model 6700S
AUG / 4 097
Classification:
Class II
Manufacture:
Rehabilicare Inc.
· 1811 Old Highway 8 New Brighton, MN 55112 Phone No. (612) 631-0590
Contact:
Gary L. Moore Phone No. (612) 638-0437
Predicate Products:
- GV II ™ Neuromuscular Stimulator, Model 9700/7000S, K881082 -
- Neuromuscular II (NMIII TM), Model 6800S, K840346 -
- TRI-STIM Stimulator, Muscle, Electrical Powered, Registration No. not known -
Indications For Use:
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
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Device Description:
The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.
Summary of Testing:
The output wave form, amplitude, pulse width, pulse rate, treatment time, NMS off time, NMS ramp up time and NMS ramp down time have been verified to the technical requirements listed in the operators manual. All measurements were taken at room temperature (72°C) with a relative humidity of 50% using a calibrated 5V power supply with a maximum capacity of 3 ampere continuous current and calibrated measurement equipment. These values are within and/or identical to the operating parameters of the predicate devices. The Ortho Dx neuromuscular stimulator uses the same power supply and proposes no additional safety considerations than the legally marketed predicate devices (NM II/III and GV II). The Line Powered Repac10 employees a UL approved power supply and is legally marketed with the predicate devices (NM II/II and GV II).
Substantial Equivalence Summary:
The Ortho Dx ™ is a neuromuscular stimulator with a symmetric biphasic output wave form identical to the Mentor Neuromuscular II (NM III ™ ), Model 6800S, Neuromuscular Stimulator, Registration Number, K840346, and a high volt pulsed current output wave form identical to the GV II M Model 9700, High Voltage Pulsed Galvanic Stimulator, Registration Number, K881082. This type of unit, combining both types of output wave forms, is similar to a predicate device, the TRI-STIM ™ , Stimulator, Muscle, Electrical Powered, manufactured by Henley, a Division of Maxxim Medical, 104 Industrial Blvd., Sugarland, TX 77478 (registration number unknown).
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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 its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary L. Moore Director of Engineering Rehabilicare Inc. 1811 Old Hiqhway 8 New Brighton, Minnesota 55112
AUG / 4 1997
Re : K971542 Ortho Dx™ Neuromuscular Stimulator Regulatory Class: II Product Code: IPF Dated: July 29, 1997 Received: August 4, 1997
Dear Mr. Moore:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Gary L. Moore
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510(K) prematice notification: - tho legally Finding of Bubboandar organisation a classification for your markets production permits your device to proceed to the market.
If you desire specific advice for your device on our labeling i regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the Office or compriation as (compranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Statement for Indication of Use:
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used - to, relax muscle spasm, prevent or retard disuse … atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
Sign-Off
51.JK, Number
Prescription Use
(Per 21 CFR 801.109)
§ 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).