(52 days)
The Lumbofix® Conductive Garment:
- provides symptomatic relief and management of chronic and intractable pain in the lower back region and
- assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back.
It is intended for prescription use only.
The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.
This document (K091317) is a 510(k) summary for the Lumbofix® Conductive Garment. It does not contain a study to prove acceptance criteria in the manner typically found for AI/ML-based medical devices. This device is a Class II Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, and its submission relies on substantial equivalence to a predicate device rather than a new clinical study with specific acceptance criteria that would require performance metrics like sensitivity, specificity, or accuracy.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of device submission.
Here's a breakdown of what can be extracted from the provided text based on the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for a Class II medical device, the "acceptance criteria" are not defined by specific performance metrics (like sensitivity, specificity, etc.) but rather by demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, and does not raise different questions of safety or effectiveness.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in K091317) |
|---|---|
| Same Intended Use as Predicate Device | Yes. The Indications for Use for the Lumbofix® Conductive Garment are to provide symptomatic relief and management of chronic and intractable pain in the lower back region and assist in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. This aligns with standard TENS device indications. |
| Similar Technological Characteristics to Predicate Device | Yes. The submission states, "There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission." The device is a conductive garment for use with TENS. |
| Does not raise different questions of safety or effectiveness | Yes. The FDA review concluded that the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission did not involve a test set for evaluating specific performance metrics of a novel algorithm or diagnostic tool. The submission is for a physical medical device (conductive garment) based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth was established by experts for a test set in the context of an AI/ML algorithm.
4. Adjudication method for the test set
- Not Applicable. No test set requiring expert adjudication was conducted.
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 a conductive garment, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is not an algorithm.
7. The type of ground truth used
- Not Applicable. Ground truth in the context of diagnostic accuracy is not relevant for this device. The "truth" for this submission is whether the device meets the characteristics of a substantially equivalent TENS accessory.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth in this context was established.
Summary from the document for context:
- Device Name: Lumbofix® Conductive Garment, Type 420 Back
- Common Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief
- Classification: Class II
- Predicate Device: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit (K082190) by Bio-Medical Research Ltd.
- Justification for Equivalence: "No new clinical studies have been submitted as part of this premarket notification. The Lumbofix® Conductive Garment has been CE marked under the EU Medical Device Directive 93/42/EEC (NB No. 0366)." and "There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission."
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Image /page/0/Picture/0 description: The image shows a logo with the letters "BMR" in a stylized font. The letters are arranged horizontally, with a curved line above and below them. The logo has a textured appearance, as if it were printed on a rough surface. The logo is simple and modern, and it would be suitable for a variety of businesses or organizations.
+353 (0)91 774300 Fax: +353 (0)91 774301
99121
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
1. Contact Details
| Name: | Anne-Marie Keenan |
|---|---|
| Address: | Bio-Medical Research Ltd.,Parkmore Business Park, WestGalway, Ireland |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | 30th April 2009. |
2. Device Name
| Trade Name of Device: | Lumbofix® Conductive Garment, Type 420 Back |
|---|---|
| Common Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Classification: | Class II |
| Product Code: | G̀ZJ |
3. Identification of Equivalent Legally Marketed Device
| Device Trade Name: | Baxolve XP Conductive Garment Accessory & LumbarSupport Kit |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd |
| 510(k) No: | K082190 |
4. Description of Device
The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS). It aids in the placement of electrodes and secures them in place. Contents include a conductive belt, a pack of hook backed electrodes and instructions for use.
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5. Indications for Use
The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back. It is intended for prescription use only.
6. Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Lumbofix® Conductive Garment. Substantial Equivalence has been demonstrated as part this 510k submission.
7. Clinical and Non-Clinical Tests
Bio-Medical Research 1.td. ("BMR") has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. Bio-Medical Research Ltd. (Slendertone & Neurotech) complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003 Medical Device Quality Management System for the design, manufacture and distribution of electro-medical devices.
No new clinical studies have been submitted as part of this premarket notification. The Lumbofix® Conductive Garment has been CE marked under the EU Medical Device Directive 93/42/EEC (NB No. 0366).
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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right side.
Public Health Service
JUN 25 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio-Medical Research Ltd c/o Ms. Anne-Marie Keenan Quality/Regulatory Engineer Parkmore Business Park West Galway Ireland
Re: K091317
Trade Name: Lumbofix® Conductive Garment, Type 420 Back Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: April 30, 2009 Received: May 28, 2009
Dear Ms. Keenan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your coetermined the device is substantially equivalent (for the indications forcronood above and in rise enclosure) to legally marketed predicate devices marketed in interstate 101 too surver in the May 28, 1976, the enactment date of the Medical Device Amendments, or to eoninored prior of ride 2011-11-2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110-) the researce, subject to the general controls provisions of the Act. The r ou may, merelore, maines of the Act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classifical controls. Existing major regulations affecting your device can be finay be subject to cademical Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the over of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toast of advised that 1 Dris assumes over device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I cacal statuted und regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY art 607); idocing (21 OFR 803); good manufacturing practice requirements as set device-related daverse ovents) (21 CFR Part 820); and if applicable, the electronic form in the quant) systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Anne-Marie Keenan
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Keira Alexander for
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name:
Lumbofix® Conductive Garment
Indications for Use:
The Lumbofix® Conductive Garment:
- 『 provides symptomatic relief and management of chronic and intractable pain in the lower back region and
- assists in the frequent and correct positioning and repositioning of pads on difficult to . reach and/or large locations of the lower back.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dexter 6/24/09
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number ___$\qquad$ K091317
§ 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).