(51 days)
The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.
The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.
The provided text primarily focuses on the 510(k) summary and FDA clearance for the PILL PHONE medication reminder software device. It details the device's classification, predicate devices, and a brief description of its features. However, it does not include any information about formal acceptance criteria or a study proving the device meets specific performance criteria.
The document is a regulatory submission for market clearance based on substantial equivalence to existing devices, not a scientific study reporting performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, expert qualifications, or ground truth establishment.
The relevant sections are:
- 1. A table of acceptance criteria and the reported device performance: Not found in the document.
- 2. Sample sized used for the test set and the data provenance: Not found in the document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found in the document.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not found in the document.
- 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 found in the document. The device is a standalone software, not an AI assistance tool for human readers in a diagnostic context.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "software that operates on a user's cell phone or other wireless device" and is a "medication reminder and information system." This strongly implies a standalone algorithm providing reminders and information. However, no specific performance study is mentioned.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance study is described.
- 8. The sample size for the training set: Not found in the document.
- 9. How the ground truth for the training set was established: Not applicable, as no training set or ground truth for it is described.
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MAR 2 9 2006
510(k) SUMMARY
Vocel
PILL PHONE Medication Reminder Software Device 510(k) Premarket Notification
Submitter
Vocel 13400 Sabre Springs Parkway Suite 255 San Diego, CA 92128
Contact Person: Mr. Chris Nelson Date Prepared: January 27, 2006
Name and Classification of Device
Trade or Proprietary Name: PILL PHONE Common Name: Classification Name: Product Code :
medication reminder system daily assist device unknown
Predicate Devices
The PILL PHONE is substantially equivalent to the ONCELLRX, the MEDPARTNER, and various medication reminder systems marketed by E-Pill, LLC.
Description of the PILL PHONE
The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and four horizontal lines above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 y 2006
Vocel C/O Mr. Keith A. Barritt Fish & Richardson, Professional Corporation 1425 K Street, N.W. Suite 1100 Washington, DC 20005
Re: K060298
Trade/Device Name: Pill Phone Regulation Number: 890.5050 Regulation Name: Daily activity assist device Regulatory Class: I Product Code: NXQ Dated: February 3, 2006 Received: February 7, 2006
Dear Mr. Barritt:
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 (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 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.
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Page-2 Mr. Keith A. Barritt
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.
This letter will allow you to continue 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) 276-0115. 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/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D. Director Division of Dental, Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K060298 510(k) Number (if known):
Device Name: PILL PHONE
Indications For Use:
The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. Watts
whilegy, General Huspin Dental Dovices
Page 1 of /
11 :
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.