(128 days)
The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
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The provided text is a 510(k) premarket notification for a medical device called "TRACTION SYSTEM, DIGIT-TRAC 930." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study to establish safety and effectiveness from scratch.
Therefore, the document does not contain information about acceptance criteria, clinical studies with sample sizes, expert ground truth, or AI performance metrics as it would for a novel AI/software medical device.
Instead, the "study" proving the device meets acceptance criteria in this context refers to the comparison of the new device to predicate devices and adherence to electrical safety and electromagnetic compatibility (EMC) standards.
Here's the breakdown of the information that can be extracted or reasonably inferred based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from regulatory requirements) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Intended Use | The device's intended use must be the same as or very similar to legally marketed predicate devices. | The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body. This matches the intended use of the predicate devices. |
| Technological Characteristics | The device's technological characteristics must be substantially equivalent to predicate devices. Deviations must not raise new questions of safety or effectiveness. | The document states: "The TRACTION SYSTEM, DIGIT-TRAC 930 has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." While specific characteristics are not detailed, the FDA's clearance implies that the technological characteristics were deemed substantially equivalent to the predicate devices (TEC VARI-TRAC II TRACTION UNIT and DYNATRON 900). This would typically include aspects like operating principles, force ranges, control mechanisms, etc., which are common to powered traction equipment. |
| Electrical Safety | Compliance with recognized electrical safety standards to ensure patient and user safety. | "Electrical Safety (EN 60601-1) testing have been done to validate the electrical safety of the device." This indicates the device passed EN 60601-1, meeting the acceptance criteria for electrical safety. |
| EMC (Electromagnetic Compatibility) | Compliance with recognized EMC standards to ensure the device operates without causing or being susceptible to electromagnetic interference. | "EMC (EN 60601-1-2) ... testing have been done to validate the electrical safety of the device." This indicates the device passed EN 60601-1-2, meeting the acceptance criteria for EMC. |
| Safety and Effectiveness | Overall demonstration that the device is as safe and effective as the predicate device(s). | The FDA's clearance letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device." This is the ultimate "reported performance" regarding safety and effectiveness for a 510(k), meaning the FDA accepted the demonstration of substantial equivalence. |
The following points address the other requested information, noting that most are not applicable to this type of device submission:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device. This is a hardware device (powered traction equipment), not a software/AI device that would typically have a "test set" of data in the sense of patient images or other clinical records. The "tests" mentioned are technical standards for electrical safety and EMC.
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. Ground truth in the context of clinical data for AI/software is not relevant here. The "experts" involved would be electrical engineers and regulatory experts who performed and reviewed the technical standard testing (EN 60601-1 and EN 60601-1-2) and the comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" of clinical cases requiring adjudication in this submission.
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. This is not an AI-powered device, and no MRMC study was conducted or required for this 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this device, "ground truth" relates to compliance with engineering standards and demonstration of similar design and function to established devices. The "ground truth" for the electrical safety and EMC tests is the defined requirements of the EN 60601-1 and EN 60601-1-2 standards.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no training set as would be used for machine learning.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
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EVER PROSPEROUS INSTRUMENT, INC. Models: TRACTION SYSTEM, DIGIT-TRAC 930
| 510K: | K052453 | |
|---|---|---|
| • | Manufacturer : | EVER PROSPEROUS INSTRUMENT, INC.Registration # 1000635107Owner ID# 9075179 |
| • | Address : | 4F, No.2 & 4F, No.4, Alley 59, Lane 42Ming-Chuan Road, Hsin-Tien, Taipei HsienTaiwan |
| • | Official Correspondent: | Dr. Jen, Ke-MinNo.58, Fu-Chiun Street, Hsin Chu City,30067, Taiwan |
| • | Classification name: | Powered Traction Equipment |
| • | Product Code: | ITH, Class II |
| • | Regulation Number: | 890.5900 |
| • | Proprietary name: | TRACTION SYSTEM, DIGIT-TRAC 930 |
| • | Common name of device: | POWERED TRACTION EQUIPMENT |
| • | Predicate Device: | 1. K862846TEC VARI-TRAC II TRACTION UNIT |
| 2.K993919DYNATRON 900 |
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Statement of Intended Use: The TRACTION SYSTEM, DIGIT-TRAC 930 is
intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's bodv.
Caution:
The device is for "prescription-use only."
Comparison to Predicate Devices: The TRACTION SYSTEM, DIGIT-TRAC
930 has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, EMC (EN 60601-1-2) and Electrical Safety (EN 60601-1) testing have been done to validate the electrical safety of the device. The comparison and validation results presented in this 510k notification to the FDA that means the subject device is substantially equivalent to predicated devices and are safe and effective in its intended use.
believe - that - the - TRACTION - SYSTEM. Wc -DIGIT-TRAC 930 is substantially equivalent to the predicate devices, i.e., TEC VARI-TRAC II TRACTION UNIT in K862846 and DYNATRON 900 in K993919, and the data provided support the safety and effectiveness of TRACTION SYSTEM, DIGIT-TRAC 930 for the intended uses.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
Ever Prosperous Instrument, Inc. c/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin Chu City, Taiwan 30067
Re: K052453
Trade/Device Name: Digit-Trac 930 Traction System Regulation Number: 21 CFR 890.5900 Regulation Name: Equipment, Traction, Powered Regulatory Class: II Product Code: ITH Dated: December 25, 2005 Received: January 03, 2006
Dear Dr. Jen:
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 such 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); good manufacturing practice requirements as set
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Page 2 - Dr. Ke-Min Jen
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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Indications for Use
K052453 510(k) Number:
Device Name: EVER PROSPEROUS INSTRUMENT, INC. TRACTION SYSTEM, DIGIT-TRAC 930
INTENDED USE
The TRACTION SYSTEM, DIGIT-TRAC 930 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Korz453 510(k) Number__
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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).