(206 days)
Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.
The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.
The provided text is a 510(k) summary for a medical device called "Hang Ups InvertAlign." This document primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device's technological characteristics and intended use. It does not contain information on acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such a study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document because it does not exist within the provided text. Similarly, I cannot answer the other questions about study specifics (sample size, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, training set details) as this information is not present.
The document's "Summary of Safety and Effectiveness" section focuses on the historical use of inversion and the features of the device that contribute to safety and effectiveness, rather than a formal study with acceptance criteria and measured performance.
In summary, the requested information about acceptance criteria and a study proving their fulfillment is not available in the provided 510(k) summary.
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DEC 2 0 1999
510(k) Summary for Hang Ups InvertAlign
| Submitter: | Roger C. TeeterHang Ups Div. of STL International, Inc.10004 - 162nd St. Ct. EPuyallup, WA 98375Phone: (253) 840-5252Fax: (253) 840-5757 | ||
|---|---|---|---|
| Contact: | Same as above. | ||
| Date prepared: | December 17, 1999 | ||
| Name of device: | Hang Ups InvertAlign | ||
| Common or Usual Name: | Rotation-Powered Gravity-Assisted Traction TableInversion Table | ||
| Classification Name: | Equipment, Traction, Powered | ||
| Predicate Devices: | F5000-SeriesInverChairVax-DATT-300Midland Vari-trac II | 510(k) ExemptK821002K951622K944699K862746 | HSTITHITHITHITH |
Device Description:
The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The user straddles the main shaft of the InvertAlign and while resting his seat on the base of the table frame, the user places each foot on the foot platform. The user's ankles slide between the foam padded ankle clamps. In the InvertAlign's full upright position, the user will be reclined in the supine position at approximately 10 degrees off vertical. By pulling the locking pin and locking the clamps securely to the ankles, the user or supervisor is able to manually adjust the foam clamps to form a secure but comfortable fit. The user or supervisor may then use the tilt control button to increase / decrease the angle of inversion. The InvertAlign can be stopped at any angle and is able to tilt beyond ninety degrees from horizontal to allow the user to hang and move freely at full inversion.
Intended Use:
The InvertAlign is a non-invasive traction device that utilizes gravity to apply traction. The traction force is a result of the natural force of gravity, and is affected only by the user's (510(k) Summary, cont.)
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pg 4 96
body weight and angle of invertAlign is indicated to increase intervertebral dimensions, to decrease pressure on the intervertebral discs, to stretch and relax muscles, and to temporarily relieve back pain associated with the listed conditions. Explanations for these claims are found in Appendix C.
Technological Characteristics:
The InvertAlign is a gravity-assisted traction device. The traction force applied to the body is a measure of the user's weight and angle of inversion. The InvertAlign itself does not apply a mechanical force to the body. The device to which the InvertAlign is most similar is the F5000III Inversion Table. Essentially, the only difference between these two devices is that the InvertAlign is operated by a motor. The InvertAlign tilts with the help of motorized controls, whereas the F5000II uses the body's arm movements to control the angle of inversion. With the motor, this upgraded inversion table no longer requires the users to adjust the table to individual height settings, reducing the possibility of user error.
Another device to which the InvertAlign is very similar is the InverChair. The main difference between these two devices is the body position in which the device places the user. The InverChair is a motorized device which inverts the patient in a 90/90 position (seated). The InvertAlign inverts the user in a standing, supine position. By allowing for a full-body inversion experience, the InvertAlign gives the body a chance to stretch and perform body-enhancing exercises.
The other three devices to which the InvertAlign is compared, the Vax-D, ATT-300, and Midland Vari-trac II, physically apply a traction force to the body. This is the vital difference between these devices and the InvertAlign the InvertAlign allows for a natural form of traction, whereas the Vax-D, ATT-300, and Midland Vari-trac II make use of a mechanically applied form of traction. The InvertAlign is a safer alternative form of traction because it relies on gravity and the user's body weight to apply the traction force. The InvertAlign is easy to use and does not require the help of a medical supervisor to operate. The InvertAlign may be returned upright at any time and requires only one user-sensitive adjustment-the foot clamps must be fitted to the users' ankles.
Summary of Safety and Effectiveness:
Inversion has been used since the age of Hypocrites and has been widely accepted as a natural form of traction in the United States since the 1960's. The fundamental purpose of the Hang Ups InvertAlign is to permit the application of inversion to the ankles, knees, hips and spine (all weight-bearing joints). The important attributing to the safety and effectiveness of the device include the easy-to-use controls which require only one user-specific adjustment (i.e.: adjustable ankle clamps), the moderate, controlled rate of inversion and ascension, and the use of gravity to apply a natural and non-invasive traction force to weightbearing joints. The emergency ascension crank may be used in the event of a power outage to return the user to an upright position.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes.
AUG 2 5 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger C. Teeter STL International, Inc. 10004 - 162nd Street, Ct. E. Puyallup, Washington 98375
Re: K991835 Trade Name: Hang Ups InvertAlign Regulatory Class: II Product Code: ITH Dated: December 17, 2000 Received: December 17, 2000
Dear Mr. Teeeter:
This letter corrects our substantially equivalent letter of December 20, 1999, which incorrectly identified your device as a prescription use device on the indications for use enclosure.
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 (QS) 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.
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
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Page 2 - Mr. Roger C. Teeter
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 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (301) 594-4037. Additionally, for quee at (301) 594-4639. Also, please note the regulation prease contact the Office or Comphanes as (as a ) Dotification" (21 CFR 807.97). Other general entitled, "Misoraliding by releveles to promation hours be obtained from the Division of Small information on your responsionnes ander the new now (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neville Jackson
4- Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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): K991835
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indication for Use:
Hang Ups InvertAlign is intended to be used for inversion, a method of gravity-assisted traction that utilizes the user's own body weight. Inversion is indicated of gray intervertebral dimentions, decrease pressure on the intervetebral discs, stretch and relax muscles, and temporarily relieve back pain associated with the listed contitions.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-the-Counter Use
Arnold Sager
(Division Sign-Off) Division of Cieneral Restorative Devices 510(k) Number _
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with three wings, symbolizing health, services, and human concerns. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
DEC 2 0 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger C. Teeter STL International, Inc. 10004 - 162nd Street, Ct. E. Puyallup, Washington 98375
Re: K991835 Trade Name: Hang Ups InvertAlign Regulatory Class: II Product Code: ITH Dated: December 17, 1999 Received: December 17, 1999
Dear Mr. Teeter:
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 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 (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 (QS) 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.
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.
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Page 2 - Mr. Roger C. Teeter
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) 594-4595. 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, "Mishranding 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,
tocoe
Jim È. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
§ 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).