(171 days)
The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.
The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. Actical is a physiological data recorder consisting of a data recorder which can be worn on the waist (hip), wrist, or ankle of the subject and that detects, measures, and records physical Activity data. A Reader is used to transfer the recorded rata to a Personal Computer (PC) running the Actical Host software. The host software is used to configure the data recorder for data collection, to retrieve logged data from the recorder, to display data and trend graphs, and to provide a means to store the logged data in a PC for later use.
The provided text is a 510(k) summary for the Actical Physiological Signal Recorder. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies, or the methodologies used to establish ground truth.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily covers:
- Contact person and date
- Trade name, common name, classification, and product code
- Legally marketed substantially equivalent predicate devices
- Description of the device
- Intended Use
- Comparison of technical characteristics, stating that "Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent." However, it does not detail these tests, criteria, or results.
- FDA's letter of clearance, confirming substantial equivalence.
Without a detailed study report, specific acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies cannot be described.
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Actical
510(K) SUMMARY
Image /page/0/Picture/5 description: The image shows the logo for Respironics Inc. The logo consists of a triangle with a stylized figure inside, followed by the text "RESPIRONICS INC." The address "1001 Murry Ridge Lane, Murrysville, PA 15668" is printed below the company name.
510(k) Summarv ACTICAL
$807.92 (a)(1) Contact Person:
Zita Yurko Manager, Regulatory Affairs October 14, 2005
8807.92 (a)(2)
Trade Name: Common Name: Classification Name: Product Code:
Date of Summary Preparation:
Actical Physiological Signal Recorder Physiological Signal Conditioner GWK
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Device:
Actiwatch® (K983533) Actiware-Sleep (K011430) Actiheart (K052489)
8807.92 (a)(4)
Description of Device:
The subject device can be classified as physiological signal conditioner as described in 21 CFR 882.1845. Actical is a physiological data recorder consisting of a data recorder which can be worn on the waist (hip), wrist, or ankle of the subject and that detects, measures, and records physical Activity data. A Reader is used to transfer the recorded rata to a Personal Computer (PC) running the Actical Host software. The host software is used to configure the data recorder for data collection, to retrieve logged
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data from the recorder, to display data and trend graphs, and to provide a means to store the logged data in a PC for later use.
8807.92 (a)(5)
Intended Use:
The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.
$807.92 (a)(6)
Comparison of Technical Characteristics:
The Actical System and the predicate devices are very similar in materials, design, function, and technological characteristics. Modifications to hardware and software subsystems of the predicate device system allow the subject device system, Actical, to record activity that is representative of energy expenditure. Results of performance tests, risk analysis, and verification and validation testing demonstrate that the devices are substantially equivalent. Accepted and voluntary standards are followed in the design, manufacture, and operation of this product.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics. Inc. % Intertek Testing Services Mr. Neil Devine 2307 East Aurora Road Twinsburg, Ohio 44087
Re: K060919
Trade/Device Name: Actical Regulation Number: 21 CFR 882.1845 Regulation Name: Physiological signal conditioner Regulatory Class: Class II Product Code: GWK Dated: September 6, 2006 Received: September 7, 2006
Dear Mr. Devine:
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.
SEP 2 2 2006
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 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.
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Page 2 - Mr. Neil Devine
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 was Sonseance Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Ho60919
Device Name:
Indications for Use:
The Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Statae Buetista nim
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060919
§ 882.1845 Physiological signal conditioner.
(a)
Identification. A physiological signal conditioner is a device such as an integrator or differentiator used to modify physiological signals for recording and processing.(b)
Classification. Class II (performance standards).