(135 days)
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:
- Protruding discs
- Bulging discs
- Herniated discs
- Degenerative disc disease
- Posterior facet syndrome
- Acute facet problems
- Radicular pain
- Prolapsed discs
- Spinal root impingement
- Hypomobility
- Degenerative joint disease
- Facet syndrome
- Compressions fractures
- Joint pain
- Discogenic pain
The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.
The provided text is a 510(k) Summary Statement for the Mettler Traction Device, MTD 4000. It details the device's description, intended use, and a comparison to predicate devices for substantial equivalence.
However, the document does not contain information about specific acceptance criteria for a study, nor does it present the results of a study designed to prove the device meets such criteria.
The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance, a common requirement for new or higher-risk devices.
Therefore, I cannot fulfill your request for the following information based solely on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing technological characteristics to predicate devices.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or study data is described.
- 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): No ground truth establishment or expert involvement in a study is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication is mentioned.
- 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: This device is a physical traction device and does not involve AI or human readers in the context of diagnostic interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned in relation to performance criteria.
- The sample size for the training set: Not applicable as it's not an AI/ML device that requires training.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is a comparison table of the MTD 4000 with predicate devices, highlighting similar features and differences in physical characteristics and user interface configurations. This comparison serves to demonstrate substantial equivalence, rather than meeting specific performance acceptance criteria from a study.
The FDA's letter (Page 3-4) states that they "have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This confirms the nature of the submission and review process.
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OCT - 8 2009
510(k) SUMMARY STATEMEMT
Mettler Traction Device, MTD 4000
Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805
Telephone: 714-533-2221 x324 714-533-3860 Fax:
- Robert E. Fleming Contact: Director, QA/RA
Date Prepared: May 21, 2009
Proposed Device Name:
-
a. TRADE NAME: MTD 4000
b. CLASSIFICATION NAME: Equipment, Traction, Powered (Sec. 890.5900, Product Code ITH) -
c. COMMON NAME: Powered Traction Device
Predicate Devices:
a. TRADE NAME: Triton/Tru-Trac/TX/Triton DTS Traction Device by Chattanooga.
b. 510(k) Number: K053223
- c. TRADE NAME: TM-300 by ITO Co., Ltd.
- d. 510(k) Number: K992545
Description of Proposed Device:
The MTD 4000 (Mettler Traction Decompression) system is an easy to use device that offers static and intermittent traction with user definable hold, rest, and treatment times. It gently pulls the cervical spine or lumbar spine in opposite directions to draw the soft tissue around the cervical or lumbar joints and separate the distance between bone sections of the vertebra.
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The MTD 4000 may be used to help relieve peripheral radiation/sciatica and pain associated with: protruding discs, spinal root impingement, bulging discs, hypomobility, herniated discs, degenerative joint disease, degenerative disc disease, facet syndrome, posterior facet syndrome, compressions fracture, acute facet problems, radicular pain, discogenic pain and prolapsed discs.
Some of the features of the MTD 4000 are:
- Easy to use �
- Active displays show all treatment parameters and progress. �
- Multiple sensors and safety controls �
- High strength traction cable �
- Adjustable Hold/Rest times �
- Continuous and Intermittent traction with multiple speed selection �
- Smooth, quiet operation �
Proposed Device Intended Use Statement:
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:
- Protruding discs �
- Bulging discs �
- Herniated discs �
- Degenerative disc disease �
- � Posterior facet syndrome
- Acute facet problems �
- Radicular pain �
- Prolapsed discs �
- Spinal root impingement �
- Hypomobility �
- Degenerative joint disease �
- Facet syndrome �
- Compressions fractures �
- Joint pain �
- Discogenic pain ◆
Comparison of Technological Characteristics Between Proposed and Predicate Devices:
Similarities:
-
- Indications for use for the MTD 4000, and the aforementioned predicates are essentially the same, all related to powered traction treatment.
-
- All have similar operating modes.
-
- Each is provided with similar accessories.
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Differences:
-
- Physical shape and size of the enclosure.
-
- Configuration of user interface controls.
-
- Display methods.
Comparison Table
| Feature | MTD 4000 | Triton / Tru-Trac /TX Traction | TM-300 |
|---|---|---|---|
| Distributor /Manufacturer | Mettler Electronics | Chattanooga Group | Ito Co., Ltd. |
| 510k | K051938 | K992545 | |
| Mains Supply | AC 110 | 100~240V / 50/60Hz | AC 110 |
| FDA Class | II | II | II |
| CE Classification | Class IIa, Type BFMDD 93/42/EEC | Class 1, Type BMDD 93 /42 /EEC | Class I, Type B |
| CE Mark | CE 0434 | CE 0413 | CE (MDD) |
| Dimensions (in) | 12.2(W) x 14.2(D)x 9.1(H) | 9.5(W) x 17.5(D) x17.5(H) | 10.2(W) x 13(D) x9.8(H) |
| Weight (pounds) | 32 | 30 | 26 |
| User interface | Membrane, controlknob | Touch screen,buttons | Membrane |
| Patient safetyswitch | Yes | Yes | Yes |
| Treatment Time(min) | 1-99 | 1-99 | 1-99 |
| Hold Time (sec) | 0-99 | 0-99 | 1-99 |
| Hold Force (lbs) | 7-198 | 0-200 | 2-198 |
| Rest Time (sec) | 0-99 | 0-99 | 1-99 |
| Rest Force (lbs) | 0-196 | 0-200 | 0-196 |
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mettler Electronics, Corporation % Mr. Robert E. Flemming Director, QA/RA 1333 South Claudina Street Anaheim, California 92805
OCT - 8 2009
Re: K091540
Trade/Device Name: MTD 4000 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: August 18, 2009 Received: August 19, 2009
Dear Mr. Flemming:
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 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 (OS) 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 - Mr. Robert E. Flemming
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/McdicalDcvices/Safety/ReportalProblem/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
ely yours,
For
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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Attachment 1b
Page of
510(k) Number (if known):
Device Name:
MTD 4000
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles.
The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with:
- Protruding discs
- · Bulging discs
- · Herniated discs
- · Degenerative disc disease
- · Posterior facet syndrome
- · Acute facet problems
- · Radicular pain
- · Prolapsed discs
- · Spinal root impingement
- · Hypomobility
- · Degenerative joint disease
- · Facet syndrome
- · Compressions fractures
- · Joint pain
- · Discogenic pain
HARRY M. CLARY FOR M. MELKERSON
Division Signer
(Bivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091540
Prescription Use × (Per CFR 801 Subpart D) AND/OR
Over the Counter Use (Per 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)
ర్లాల
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).