(89 days)
Not Found
No
The description details a mechanical traction device with programmable force and time settings, but there is no mention of AI or ML capabilities for analysis, adaptation, or decision-making.
Yes
The device is described as a treatment for conditions such as spinal root impingement, joint hypomobility, and discogenic pain, indicating a therapeutic purpose.
No
The device is described as providing "traction and mobilization" and is "indicated for use as a treatment" for various spinal conditions, clearly indicating a therapeutic, rather than diagnostic, purpose.
No
The device description clearly outlines hardware components such as a DC-powered motor gearbox, rope drum, clutch, and harnesses, indicating it is a physical medical device, not software-only.
Based on the provided information, the ATP9 traction device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- ATP9 Function: The ATP9 traction device is used to apply physical force (traction and mobilization) to the lumbar and cervical spine. It is a therapeutic device used directly on the patient's body, not for analyzing samples.
- Intended Use: The intended use clearly describes a physical therapy treatment for musculoskeletal conditions.
- Device Description: The description details mechanical components and how it applies force to the patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, laboratory procedures, or diagnostic testing.
Therefore, the ATP9 traction device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
Product codes (comma separated list FDA assigned to the subject device)
ITH
Device Description
The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and cervical muscles and vertebrae
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)
Not Found
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
HUNTLEIGH HEALTHCARE7324461938 NOV. 9. 1999 11:42AM
| Nov 10 1999 | K 992733 |
|---|---|
| 510(k) Summary | |
| Akron ATP9 Traction Machine | |
| Submitters Name: | Audrey Witko |
| V.P., Administration & Compliance | |
| Huntleigh Healthcare Inc. | |
| 227 Route 33 East | |
| Manalapan, NJ 07726 | |
| Telephone: (732) 446-2500 | |
| Fax: (732) 446-1938 | |
| Name of Device: | Akron ATP9 Traction Machine |
| Manufactured By: | Huntleigh Akron |
| 1 Farthing Road | |
| Ipswich, Suffolk IP1 5AP | |
| United Kingdom | |
| Classification Name: | Power traction equipment (21 CFR §890.5900) ITH |
| Predicate Devices: | TEC Traction Machine (K834405) |
| ESCOTEK EST TRAC 401 (K844385) |
Device Description:
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical muscles and vertebrae when used in conjunction with fixed or variable height traction tables. It is indicated for use as a treatment for spinal root impingement, joint hypomobility, degenerative joint disease, discogenic pain and compression fractures.
The ATP9 machine mounts on available Akron traction tables and mobile traction stand. Traction force is applied to the patient using Akron traction harnesses. The ATP9 utilizes a DC-powered motor gearbox connected to a rope drum via a clutch. The rope is connected to a harness attached to the patient. The high force hold time and low force rest time programs are selectable from 1 second minimum to 99 seconds maximum, with a high traction force range of 2-200 lbs. and low traction force range of 2-196 lbs. There are seven combinations of therapy including static, intermittent, progressive, regressive and cyclic.
Safety Considerations:
There are eleven fault conditions detected by the ATP9 including, control system Failure, low supply voltage, AC power failure, motor power supply failure, battery failure, excess tension detected, high force control setting failure, strain gauge failure, strain gauge mismatch, motor malfunction, unexpected increase in tension, and cord drive fault. The ATP9 conforms to the following international standards: IEC601-1, EN60601-1-2: 1993, EN60601-1/A2: 1995, EN60601-1-4: 1997. Manufactured to ISO9002 and EN46002.
On, 2 - 11/60
1
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 0 1999
Ms. Audrey Witco Vice President Administration, Compliance and Clinical Affairs Huntleigh Healthcare Incorporated 227 Route 33 East Manalapan, New Jersey 07726
K992733 Re: Akron ATP9 Traction Machine Product Code: ITH Regulatory Class: II Dated: August 9, 1999 Received: August 13, 1999
Dear Ms. Witco:
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 controls provisions The general controls provisions of the Act 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. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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
2
Page 2 - Ms. Audrey Witco
requlations. 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 requlation (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 at (301) 443-6597, or at its Internet address
"http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Eriller los Mesen essame Chuliatorgiene Henline & .. P
| 510(k) Number (if known): | K992733 |
|---|---|
| Device Name: | AKRON ATP9 TRACTION MACHINE |
| Indications for Use: |
The ATP9 traction is intended to provide traction and mobilization of lumbar and cervical
ist the and vertebrae when used in conjunction with fixed are in the below to the muscles and verte interned to provide mobilization of lumbar and cervices
tables. It is indicated to provide with fixed of variable height traction tables . It is indicated for use as a treatment with fixed or variable height he work in the mated for use as a treatment for spinal root impingement, joint
hypomobility, degenerative joint disease, discogenic pain, joint pain and compression
fracture
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF Mapped)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
Concurence of CDRH, Office of Device Evaulation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K992733 |
| 510(k) Number |
(Optional Format 3-10-98)
(Posted July 1, 1998)
Back to the Indications for Use Page
Rev. B- 1/99