(265 days)
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:
the symptomatic relief of chronic intractable pain, and
as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
As a Neuromuscular Electrostimulation (NMES) device for:
the relaxation of muscle spasms,
prevention or retardation of disuse atrophy,
increasing local blood circulation,
muscle re-education,
immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
and
to maintain or increase the range of motion.
Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.
The provided text describes a 510(k) summary for the Bioinduction Acticare HFT/HFI device, a Transcutaneous Electronic Nerve Stimulator (TENS) and Neuromuscular Electrostimulation (NMES) device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy.
The document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety testing, rather than a clinical performance study with defined acceptance criteria.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be extracted related to testing:
The device was tested in accordance with the following non-clinical standards:
- IEC 60601-2-10:2001 (Specific requirements for nerve and muscle stimulators)
- IEC 60601-1:1988 (General requirements for safety of medical electrical equipment), Amendment 1, 1991-11, Amendment 2, 1995
- IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)
- IEC 60601-1-2:2005 (EMC compatibility and additional FCC requirements)
- IEC 60601-1-4:2000 (Software for use in Medical Devices)
The conclusion states that the device has "similar technical characteristics, performances and applications" to predicate devices, and that the "information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness." This implies that the performance aspects assessed were primarily technical specifications as compared to the predicate devices and adherence to relevant safety standards. There is no mention of a clinical or analytical performance study that would typically define acceptance criteria based on diagnostic accuracy or efficacy.
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K08183S
MAR 1 9 2009
bioinduction
Document ref: QA-00106 Acticare_510(k)_Submission.doc
Revision date: March 12, 2009
1 510(k) Summary
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The Assigned 510(k) number: | K081835 |
|---|---|
| The 510(k) submitter andowner's name is: | Bioinduction Limited |
| Address and registered office: | 178-180 Hotwell Road,BRISTOL,BS8 4RP,United Kingdom |
| Telephone number: | +44 117 377 5275 |
| Fax number: | +44 117 377 5405 |
| Contact person: | Ivor S Gillbe, Chief Executive Officer |
| Date the summary wasprepared: | 21 December, 2008 |
| Proprietary Name: | Acticare |
| Common Name: | TENS (Transcutaneous Electronic Nerve Stimulator) deviceNMES (Neuromuscular Electrostimulation) device |
| Classification Name: | GZJ: Stimulator, Nerve, TranscutaneousIPF: Stimulator, Muscle, Powered |
| Predicate Devices: | Acticare is similar to the following predicate devices:As a TENS device under classification GZJ:1. Enraf Nonius Endomed 182 System (K003744),2. Skylark PGS-123 High Voltage Galvanic Stimulator (K946299)3. Rehabilicare (now Compex Technologies Inc.) ProMax TENS(K022405)4. Body Clock Health Care Ltd V-TENS Plus (K022731)As a NMES device under classification IPF5. BioStim NMS+ Electrical Neuromuscular Stimulator (K010749) |
| Device Description: | Acticare HFT/HFI is a hand-held stimulator designed to pass electricalsignals via surface electrodes through the skin to the underlying nerves ormuscles. It may be used as a TENS device to aid the blocking of painsignals traveling to the brain or as a NMES device for musclestimulation. |
Section 1: 510(k) Summary
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bioinduction
Document ref: QA-00106 Acticare_510(k)_Submission.doc Revision date: March 12, 2009
Transcutaneous Electronic Nerve Stimulation (TENS) is used for the Intended Use: symptomatic relief and management of pain and/or as an adjunctive treatment in the management of post surgical and post-traumatic acute pain. Neuromuscular Electrostimulation (NMES) is used for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis and to maintain or increase the range of motion. The device can be used in clinical, domestic and other environments. Technology Comparison to Acticare is very similar to the predicate devices and has technology Predicate Device: characteristics that are substantially equivalent to the predicate devices. Acticare and the five predicate devices all transmit clectrical pulses through the skin. The range of amplitudes, pulse widths, frequencies and polarities delivered by Acticare is within the ranges delivered by the predicate devices. Acticare and the five predicate devices can all be used in clinical, domestic and other environments. The device was tested in accordance with the tests specified in Non-clinical Testing: IEC 60601-2-10:2001 supported by the following testing below: IEC 60601-1, Medical Electrical Equipment - Part 1: General IEC 60601-11988 Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 IEC 60601-1-1:2000 Safety requirements for medical electrical systems IEC 60601-1-2:2005 EMC compatibility (and additional FCC requirements) IEC 60601-1-4:2000 Software for use in Medical Devices. Conclusion: Acticare and the four predicate devices have the same intended uses and similar technical characteristics, performances and applications. The information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness. Acticare is substantially equivalent to the predicate devices. Declaration: This summary has been compiled in accordance with FDA guidelines and includes only information that is also covered in the body of the 510(k) and does not contain any puffery or unsubstantiated labeling
Signed
Signature
Ivor S Gillbe
claims.
being a duly authorized officer of the company
on 22nd December, 2008
on behalf of Bioinduction Limited, Bristol, UK.
Acticare 510(k) application
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized wing feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAR 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bioinduction Ltd. % Ms. Krista Oakes 2300 McDermott Road, Suite 200-207 Plano, Texas 75025
Re: K081835
Trade Name: Bioinduction Acticare HFI and HFT Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, IPF Dated: February 27, 2009 Received: February 29, 2009
Dear Ms. Oakes:
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- Ms. Krista Oakes
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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{{\bioinduction
2 Statement of Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
K081835
Bioinduction Acticare HFT/HFI
As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:
the symptomatic relief of chronic intractable pain, and
as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
As a Neuromuscular Electrostimulation (NMES) device for:
the relaxation of muscle spasms,
prevention or retardation of disuse atrophy,
increasing local blood circulation,
muscle re-education,
immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
and
to maintain or increase the range of motion.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH/Office of Device Evaluation (ODE)
ion of Ceneral. I eurologica
510(k) Number
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).