(33 days)
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patient always holds a safety switch that can interrupt treatment if it becomes uncomfortable. Several "mechanical waveforms" are available for selection by the operator, including: (1) Basic intermittent traction, (2) Incremental intermittent traction, (3) Incremental and decremental intermittent traction, (4) Residual intermittent traction, (5) Incremental and residual intermittent traction, (6) Incremental, decremental and residual intermittent traction, (7) Basic continuous traction, (8) Incremental continuous traction. The residual tractive force, the duration time setting, the pause time setting, the tow speed, and the treatment time setting are all programmable up to specified limits. For forces selected above 18 kg, the system always asks for confirmation of the selected value by the operator before proceeding. A limit switch prohibits output exceeding 100 kg.
The provided K992545 510(k) Summary for the TM-300 Traction System does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and compliance with electrical safety and electromagnetic compatibility standards.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., pain reduction, disc decompression) or diagnostic accuracy. The "acceptance criteria" discussed are related to safety and manufacturing standards, and "reported device performance" is primarily about compliance with these standards and the device's functional capabilities.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with EN-60601 standard | Certificate of compliance issued by TÜV |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2 standard | Attestation of Conformity issued by TÜV |
| Design Specifications | Met design specifications (implied functional requirements like force limits, timing, waveforms) | "The design qualification testing demonstrated that the TM-300 met its design specifications." |
| Premarket Notification Requirements | Met requirements for substantial equivalence and regulatory compliance | Demonstrated Substantial Equivalence as defined in the Federal Food Drug and Cosmetic Act and guidance documents. |
2. Sample Size Used for the Test Set and the Data Provenance
No sample size for a test set or information about data provenance (e.g., country of origin, retrospective/prospective) is mentioned for clinical effectiveness or diagnostic accuracy. The testing mentioned refers to engineering and safety performance tests, not clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The submission does not describe a test set requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The device is a therapeutic traction system, not a diagnostic imaging or interpretation tool where MRMC studies are typically performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. The TM-300 is a physical medical device (traction system) that interacts directly with the patient, not a software algorithm with standalone performance. Its operation involves an operator, and a safety switch held by the patient allows interruption.
7. The Type of Ground Truth Used
For the engineering and safety tests, the "ground truth" would be established by the specifications defined during the device's design and the relevant regulatory standards (EN-60601, EN 60601-1-2). For clinical efficacy, no ground truth data from studies are provided in this submission; instead, reliance is placed on the substantial equivalence to a predicate device that presumably established its efficacy.
8. The Sample Size for the Training Set
Not applicable. This device is a physical traction system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is described for this device.
Summary of the Study/Evidence Provided in the K992545 510(k) Summary:
The provided document describes a technical performance and safety validation study rather than a clinical efficacy study. The main focus of the testing was to demonstrate:
- Compliance with electrical safety standards: The device underwent testing to ensure it met the requirements of the EN-60601 standard, with a certificate of compliance issued by TÜV.
- Compliance with electromagnetic compatibility standards: The device was tested to meet the EN 60601-1-2 standard, with an Attestation of Conformity from TÜV.
- Adherence to design specifications: "Design qualification testing demonstrated that the TM-300 met its design specifications," implying that its functional outputs (e.g., force levels, timing, waveform generation) performed as intended.
The basis for the device's clinical indications (relief of low back pain associated with herniated discs, etc.) is its substantial equivalence to a previously cleared predicate device (DRS System, K981822), rather than independent clinical trials conducted for the TM-300 itself. The submission asserts that the TM-300 has the "same indications for use and target population as the legally marketed predicate devices" and "the same technological characteristics." Therefore, the "study" proving the device meets clinical acceptance criteria is essentially the prior clearance and presumed efficacy of the predicate device.
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K992545 510(k) Summary
TM-300 Traction System
Common/Classification Name: Powered Traction Unit, 21 CFR 890.5900
lto Co., Ltd. 3-3-3 Toyotama-Minami Nerima-ku, Tokyo 176-8605 JAPAN
Contact: H. Okada , Prepared: July 29, 1999
LEGALLY MARKETED PREDICATE DEVICES A.
The TM-300 Traction System is a powered traction unit, a device classified by the regulation 21 CFR 890.5900 as a Class II device. The TM-300 Traction System is substantially equivalent to the DRS System manufactured by Professional Distribution Systems, Inc., which was cleared on June 24, 1998 as K981822.
B. DEVICE DESCRIPTION
The TM-300 Traction System is an automatic intermittent traction system for traction therapy. The patient always holds a safety switch that can interrupt treatment if it becomes uncomfortable. Several "mechanical waveforms" are available for selection by the operator, including:
- (1) Basic intermittent traction
- (2) Incremental intermittent traction
- (3) Incremental and decremental intermittent traction
- (4) Residual intermittent traction
- (5) Incremental and residual intermittent traction
- (6) Incremental, decremental and residual intermittent traction
- (7) Basic continuous traction
- (8) Incremental continuous traction
The residual tractive force, the duration time setting, the pause time setting, the tow speed, and the treatment time setting are all programmable up to specified limits. For forces selected above 18 kg, the system always asks for confirmation of the selected value by the operator before proceeding. A limit switch prohibits output exceeding 100 kg.
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c. INTENDED USE
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back The TM-300 relieves pain associated with herniated discs, pain. protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. These indications are identical to those cleared for the predicate device.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The TM-300 Traction System is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices. The TM-300 Traction System has the same technological characteristics as the predicate devices. This premarket notification has described the characteristics of the TM-300 Traction System in sufficient detail to assure substantial equivalence except for a few of the characteristics where performance testing was carried out (e.g., electrical safety).
ட். TECHNOLOGICAL CHARACTERISTICS
The TM-300 and the predicate device are line-powered traction devices. The TM-300 and the predicate device are microprocessor-based and employ digital and analog circuits to produce the specified waveforms and traction levels. Both employ an LCD screen as the user interface.
TESTING F.
Testing was carried out to assure compliance with recognized electrical safety standards. Ito was issued a certificate of compliance with the EN-60601 standard for electrical safety by TUV.
TUV has issued an Attestation of Conformity for the TM-300 in regard to the EN 60601-1-2 standard for electromagnetic compatibility.
The design qualification testing demonstrated that the TM-300 met its design specifications.
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CONCLUSION G.
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 1999
T. Whit Athey, Ph.D. Senior Consultant Ito Co., Ltd. C/O C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
K992545 Re:
Trade Name: TM-300 Traction System Regulatory Class: II Product Code: HST Dated: July 30, 1999 Received: July 30, 1999
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - T. Whit Athey, Ph.D.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications For Use:
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 relieves pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) | Proces | ||
| Division of General Restorative Devices | |||
| 510(k) Number | K992545 | ||
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
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§ 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).