(135 days)
No
The summary describes a mechanical traction device with user-definable settings, and there is no mention of AI, ML, or related concepts.
Yes
The device is intended to relieve pain and mobilize skeletal structures, indicating a therapeutic purpose.
No
The device is described as a "traction device" used for "traction and mobilization of skeletal structures and skeletal muscles" to relieve pain, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "system" and describes physical actions ("gently pulls the cervical spine or lumbar spine in opposite directions") which are indicative of a hardware device, not software alone. The predicate devices are also physical traction devices.
Based on the provided information, the MTD 4000 traction device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MTD 4000 Function: The MTD 4000 is a physical therapy device that applies mechanical traction to the spine. It works externally on the body and does not involve the analysis of biological samples.
The description clearly indicates its use for physical treatment of musculoskeletal conditions, not for diagnostic testing using biological specimens.
N/A
Intended Use / Indications for Use
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
Product codes
ITH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine or lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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 110120 /240 V
220
50/60 Hz | 100240V / 50/60120/220~240
Hz | AC 110
V
50/60 Hz |
| FDA Class | II | II | II |
| CE Classification | Class IIa, Type BF
MDD 93/42/EEC | Class 1, Type B
MDD 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) x
17.5(H) | 10.2(W) x 13(D) x
9.8(H) |
| Weight (pounds) | 32 | 30 | 26 |
| User interface | Membrane, control
knob | Touch screen,
buttons | Membrane |
| Patient safety
switch | 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 |
3
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.
4
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
5
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)
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