(96 days)
The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health.
The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.
The provided document describes the NormaTec MVP, a powered inflatable tube massager. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance evaluations with specific metrics.
Instead, the document focuses on:
- Substantial Equivalence: The primary method for FDA clearance (510(k)) is by demonstrating that a new device is as safe and effective as a legally marketed predicate device.
- Safety Testing: The document mentions "safety testing and quality assurance testing" were performed, stating that "In all instances, the NormaTec MVP functioned as intended and the results observed were as expected." It also notes compliance with electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). This is a general statement about manufacturing and basic functional checks, not a clinical performance study against specific acceptance criteria for efficacy.
- Intended Use & Technological Characteristics: Details about what the device does and how it works.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as the requested information is not present in the provided text.
Based on the available text, here's what can be inferred or directly stated:
Information from the Document:
- Table of Acceptance Criteria and Reported Device Performance: Not applicable. The document does not specify quantitative acceptance criteria or a performance study with measurable outcomes beyond general safety and functionality.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance (country, retrospective/prospective) is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described for a performance study.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable. This is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document states: "Performance data demonstrate that the MVP is as safe and effective as the predicate device." This general statement refers to the substantial equivalence argument based on similar design, intended use, and functioning as predicate devices, not a new clinical performance study with defined acceptance criteria and statistical outcomes.
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NormaTec MVP
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan Lovells 555 Thirteenth Street Washington, DC 20004-1109 Phone: 202-637-5794 Facsimile: 202-637-5910
Contact Person: Jonathan S. Kahan
Date Prepared: December 12, 2011
Name of Device and Name/Address of Sponsor
NormaTec MVP
Laura F. Jacobs, MD, PhD NormaTec Industries, LP 44 Glen Avenue Newton Center, MA 02459 Phone: 617-928-3400 Facsimile: 617-928-3430
Contact Person: Laura F. Jacobs, M.D., Ph.D.
Common or Usual Name
Powered inflatable tube massager
Classification Name
Powered inflatable tube massager IRP 21 C.F.R. § 890.5650
Predicate Devices
NormaTec PCD (K013436) Telebrand Air Press Massager (K032505) Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655)
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Intended Use / Indications for Use
The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Technological Characteristics
The NormaTec MVP is a powered inflatable tube massager. It is intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation to the treated areas. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff. The device is to be used by people who are in good health.
The NormaTec MVP consists of an air compressor with a manual pressure adjustment bleed-valve, an inflatable appliance (boot or arm sleeve). plastic air fubing connecting the device to the appliances, and an AC/DC adaptor with power cord. The appliance is divided into 5 segments, with a single tube leading from each segment to the tubing connector on the device.
Performance Data
The NormaTec MVP underwent safety testing and quality assurance testing. In all instances, the NormaTec MVP functioned as intended and the results observed were as expected. The NormaTec MVP is in compliance with electromagnetic compatibility standards IEC 60601-1 and IEC 60601-1-2.
Substantial Equivalence
The NormaTec MVP is substantially equivalent to its predicates because it has the same intended use, similar indications for use and technological characteristics. The NormaTec MVP and the predicates, the Telebrand Air Press Massager (K032505) and the Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655), are intended to temporarily relieve minor muscle aches, pains, and to temporarily increase circulation to the treated areas.
NormaTec's MVP has very similar components as its predicate devices and very similar principles of operation. Each device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the inflatable appliance, and control of pressure applied cyclically. Several of the components of the MVP are identical to its predicate, the NormaTec PCD. · The minor technological differences between the MVP and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the MVP is as safe and effective as the predicate device. Thus, the MVP is substantially equivalent.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN - 4 2012
NormaTec Industries, LP % Hogan Lovells US LLP Mr. Jonathan Kahan 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K112890
Trade/Device Name: NormaTec MVP Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP, JOW Dated: December 12, 2011 Received: December 12, 2011
Dear Mr. Kahan:
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: GDRH 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
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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 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,
Erin D. Keith
Jor Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K112890
Device Name: NormaTec MVP
Indications for Use:
The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle The Normal 80 mm - 10 th temporarily increase circulation to the treated areas.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112890
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).