(435 days)
The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Quadra Bloc TENS, Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specially designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels. The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device and controlling operation. There are two output channels, designated Left and Right. They have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (HP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under HP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency. The QuadraBloc TENS + Electrode, to be used in conjunction with the QuadraBloc TENS Model 101 is a PMI electrode with an attached QuadraBloc permanent magnet.
The provided text describes a 510(k) summary for the Quadra Bloc TENS, Model 101. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a dedicated study. Therefore, the document does not contain the detailed study information or acceptance criteria usually found in submissions for novel devices or those requiring clinical trials for performance validation.
Here's an analysis based on the information provided, explicitly stating what an answer would look like if the information were present and highlighting its absence where applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics against pre-defined acceptance criteria. | Not specified in the document as part of a performance study. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not provided. This document does not describe a performance study with a test set of data.
- Data Provenance: Not applicable/not provided. The submission is based on comparison to predicate devices and the device's inherent functional characteristics, not on a data-driven performance study.
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/not provided. This type of information is typically associated with studies where expert assessment is used to establish ground truth for evaluating diagnostic or predictive devices. The Quadra Bloc TENS is a therapeutic device for pain relief, and its approval pathway through 510(k) relies on demonstrating equivalence rather than on a study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/not provided. No test set or expert adjudication process 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/not provided. The Quadra Bloc TENS is a transcutaneous electrical nerve stimulator (TENS) for pain relief, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device type and not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/not provided. The device is a hardware TENS unit. It does not employ an algorithm in the sense of an AI or software-based diagnostic tool that would have "standalone" performance evaluated without human intervention in the loop. Its performance is related to its electrical stimulation characteristics and clinical effectiveness in pain relief, which is inferred as equivalent to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/not provided. The 510(k) submission for this TENS device focuses on substantial equivalence to predicate devices based on technological characteristics and intended use. There is no mention of a ground truth derived from expert consensus, pathology, or outcomes data to evaluate the device's performance in a study. The "truth" in this context is that the device functions similarly to legally marketed predicate devices for the same intended use.
8. The sample size for the training set
- Not applicable/not provided. There is no mention of a "training set" as this device is not an AI/ML product that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
- Not applicable/not provided. As there is no training set for this device type, the establishment of ground truth for such a set is not relevant.
Summary of Device Acceptance and Study (Based on Provided Text):
The Quadra Bloc TENS, Model 101, was accepted for market through the 510(k) premarket notification pathway. This pathway demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing performance against specific acceptance criteria through a primary clinical study.
The primary "study" or justification for acceptance presented in this document is a comparison to predicate devices.
-
Predicate Devices:
-
Demonstration of Substantial Equivalence:
- The new QuadraBloc TENS Model 101 is stated to be identical to its previously approved version (KO62547).
- The associated electrode is stated to be identical to the PMI electrode (K070807) in composition.
- The permanent magnet on the electrode is described as similar in characteristic to the ComboCare 2000 (K083202).
- The comparison mainly rests on technological characteristics, intended use, and functioning being comparable to these predicate devices. The document explicitly states: "The ComboCare 2000 TENS and the QuadraBloc TENS Model 101 are substantially equivalent."
Therefore, the "proof" that the device meets acceptance criteria (in the context of a 510(k)) is this detailed comparison demonstrating that its design, materials, and intended use are substantially equivalent to devices already on the market, implying that it is as safe and effective as those legally marketed predicates. No specific performance metrics or clinical study results from a prospective trial are included, as is typical for this regulatory pathway, especially for a device type like a TENS unit.
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501(k) Summary
OCT 2 0 2011
| A. | General Information on Submitter |
|---|---|
| ---- | ---------------------------------- |
| Name: | Gradient Technologies, LLC |
|---|---|
| Address: | 6070 Poplar Avenue, Suite 600 Memphis, TN 38119 |
| Telephone: | (901) 767-2384 |
| Fax: | (901) 767-1782 |
| Name of Contact Person: | John Townsend |
| Date Summary Prepared: | February 21, 2007 |
- B. General Information on Device Trace Name: Quadra Bloc TENS, Model 101 Classification Name: Transcutaneous electrical nerve stimulator, for pan relief Product Code: GZJ
- C. Predicate Devices
The current QuadraBloc TENS Model 101 is identical to the original QuadraBloc TENS Model 101; the modification to the QuadraBloc TENS Model 101 is identical to the PMI electrode. The ComboCare 2000 TENS and the QuadraBloc TENS Model 101 are substantially equivalent.
- D. Description of the Device
The Quadra Bloc TENS, Model 101 is a battery powered portable TENS device. The Quadra Bloc TENS, Model 101 is a prescription device that is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. The device is specially designed to be small, portable and lightweight so as to not interfere with users movements and/or functions. The electronics unit consists of a housing that contains a battery compartment, display, entry keypad, electronic system, and output channels.
The Quadra Bloc TENS, Model 101 uses four AA alkaline batteries. The display is a single line 16-character alphanumeric display. The entry keypad is used for turning the device on/off, setting parameters on the device and controlling operation. There are two output channels, designated Left and Right. They
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have a constant phase relation with each other but are independently set for amplitude. There is a separate two-wire cable for each channel. The electronics consists of a microprocessor (HP) to control and sequence all functions. It also reads the keyboard inputs. Output amplitude and display are under HP control. The electronics also boost the battery voltage to the level required for the stimulation pulse, as well as controls the timing for the pulse width and frequency. The QuadraBloc TENS + Electrode, to be used in conjunction with the QuadraBloc TENS Model 101 is a PMI electrode with an attached QuadraBloc permanent magnet.
Intended Use ﻧﻨﺎ
The Quadra Bloc TENS 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of postsurgical or post-traumatic acute pain. This is a prescription : device and should be used under continued medical supervision.
- Technological Characteristics of Device Compared to Predicate Device-ﺖ
| BrandName | Model | Shape | Size | SurfaceArea | FDA Number |
|---|---|---|---|---|---|
| PMI | WF2 | Round | 2″x2″ | 2026mm | K070807 |
- V. Indications for Use Statement
510(k) Number: K102278/S1
Device Name: Quadra Bloc TENS Model 101
Indications for Use: Prescription The Quadra Bloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunction treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Gradient Technologies, LLC c/o Mr. John Townsend, President 6070 Poplar Avenue, Sixth Floor, Memphis, TN 38119
Re: K102278
Trade Name(s): Quadra Bloc TENS Model 101 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 17, 2011 Received: October 18, 2011
Dear Mr. Townsend:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
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product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Keiva Alexander
Malvina B. Eydelman, M.D.
Malvina B. Eydelman, 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
K102278 510(k) Number (if known):
Quadra Bloc TENS Model 101 Device Name:
Indications For Use:
The QuadraBloc TENS Model 101 is intended for use in relief of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision. (Part 21 CFR 801 Sub part D)
X Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sem.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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X102278 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).