(128 days)
Not Found
No
The summary describes a mechanical traction system and lacks any mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The "Intended Use / Indications for Use" section explicitly states the device is for "exert therapeutic pulling forces on the patient's body".
No
Explanation: The device is a traction system intended to exert therapeutic pulling forces. It is used for treatment, not for diagnosing medical conditions.
No
The intended use clearly describes a "TRACTION SYSTEM" that exerts "therapeutic pulling forces on the patient's body" in conjunction with "traction accessories, such as belts and harnesses." This strongly indicates a physical device, not software alone. The predicate devices also appear to be physical traction units.
Based on the provided information, the TRACTION SYSTEM, DIGIT-TRAC 930 is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "exert therapeutic pulling forces on the patient's body." This describes a physical therapy or rehabilitation device used directly on the patient, not a device used to examine specimens (like blood, urine, or tissue) outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The TRACTION SYSTEM, DIGIT-TRAC 930 is a therapeutic device used for physical manipulation.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ITH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
EVER PROSPEROUS INSTRUMENT, INC. Models: TRACTION SYSTEM, DIGIT-TRAC 930
| 510K: | K052453 | |
|---|---|---|
| • | Manufacturer : | EVER PROSPEROUS INSTRUMENT, INC. |
| Registration # 1000635107 | ||
| Owner ID# 9075179 | ||
| • | Address : | 4F, No.2 & 4F, No.4, Alley 59, Lane 42 |
| Ming-Chuan Road, Hsin-Tien, Taipei Hsien | ||
| Taiwan | ||
| • | Official Correspondent: | Dr. Jen, Ke-Min |
| No.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. K862846 |
| TEC VARI-TRAC II TRACTION UNIT | ||
| 2.K993919 | ||
| DYNATRON 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
3
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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Korz453 510(k) Number__
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