(89 days)
The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.
The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.
Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data.
The device is not intended for emergency calls, and may not be used to send any real-time alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.
The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient; alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.
A list of compatible devices and services will be available on the Polymap Wireless website.
The Polytel® APT device performs transmission of physiological patient information to and from wireless patient monitors and a remote data server healthcare facility over an encrypted dialup Internet connection. The APT, with its built-in telephone modem, transmits data over the public switched telephone network and the dial-up Internet.
The APT is contained in a small plastic unit, containing two standard telephone jacks for connection to standard phone outlets, a 5V power input jack for connection to an AC adapter, and four indicator lights. The indicator lights are used to show the reception of a measurement from a transmitting device, to show when the telephone line is in use, and to indicate if there has been an error (delay) in transmission.
Two server-side components are involved in the operation of the APT, the first providing a centralized configuration database, the second providing for data collection and translation to a standard protocol.
The APT device is not used directly on a patient, nor attached electrically to any device that is used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
Here's a breakdown of the acceptance criteria and study information for the Polytel® APT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity, etc.) for the Polytel® APT. This is common for devices like data transmission gateways, where the focus is on functional verification rather than diagnostic performance. Instead, the "acceptance criteria" are implied by the nature of the testing performed, which aimed to demonstrate that the device functions as intended and is substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Transmission: Successfully transmit physiological patient information from wireless monitors to a remote data server/healthcare facility. | Acceptable: Bench testing using Polymap procedures and specifications, and field testing under actual use conditions demonstrated acceptable results. |
| Data Integrity: Ensure data is transmitted accurately via an encrypted dialup Internet connection. | Acceptable: Implied by the overall acceptable results of testing, indicating no reported issues with data integrity. |
| Compatibility: Receive data wirelessly from compatible devices (e.g., GMA models, blood pressure meter, weight scale, spot-check SpO2). | Acceptable: Implied by the successful field testing under actual use conditions with compatible devices. |
| Safety: Pose no significant risk to the patient or other people (as it's not used directly on a patient or electrically attached to patient-contacting devices). | Acceptable: Stated that the device "poses no significant risk to the patient or other people within the patient's home." |
| Technological Equivalence: Similar technological characteristics (Bluetooth, dial-up modems, line-powered, 2.402-2.480 GHz frequency band) to predicate devices. | Met: Explicitly stated, "The Polytel APT has technological characteristics that are very similar to those of the predicate devices, as all use Bluetooth technology and dial-up modems. All of these devices are line-powered, and each device uses the same frequency band of 2.402-2.480 GHz." |
| Compliance with Performance Standards: Adherence to relevant performance standards. | Acceptable: Performance standards testing was conducted, and the “results were acceptable.” |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical "sample size" for the test set in terms of patients or data points. However, it mentions:
- Bench Testing: Conducted using "Polymap procedures and specifications."
- Field Testing: Conducted "under actual use conditions."
The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. Given the nature of "field testing under actual use conditions," it would inherently be prospective, simulating real-world usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on a medical image) is not applicable here. The Polytel® APT is a data transmission device, not a diagnostic tool. Therefore, there's no mention of experts establishing a ground truth for a test set in the traditional sense of medical diagnosis. The "truth" in this context is whether the data is transmitted correctly and reliably.
4. Adjudication Method for the Test Set
No adjudication method is described, as it's not relevant for a device whose primary function is data transmission. The evaluation would have been based on successful transmission, data integrity, and functional operation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic tasks. The Polytel® APT is a data transmission gateway, not an AI diagnostic tool, so such a study would not apply.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The "testing" described (bench testing, field testing, and performance standards testing) evaluates the device's functional performance in a standalone capacity, without direct human intervention in its data transmission function. The device's role is to automate data transfer.
7. The Type of Ground Truth Used
As mentioned in point 3, the concept of "ground truth" (expert consensus, pathology, outcomes data) doesn't directly apply here for a data transmission device. Instead, the "ground truth" for the testing would have been:
- Expected Functional Behavior: The device should transmit data correctly and reliably according to its design specifications.
- Successful Data Reception: Data sent by the APT should be received accurately by the remote server/healthcare facility.
- Compliance with Standards: Meeting established performance standards for wireless communication and data transfer.
8. The Sample Size for the Training Set
The Polytel® APT is a hardware device for data transmission, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or machine learning. The device's functionality is based on its hardware design and firmware programming, not on being trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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K100524 Pi/
5.1
MAY 2 4 2010
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
Submitter:
Pierre Landau, PhD President Polymap Wireless 310 S. Williams Blvd. Ste. 350 Tucson, AZ 85711 (520) 747-1811 Fax: (520) 747-1811 Email: pierre@polymap.net
Same as submitter Contact Person:
May 1, 2009 Date of Summary:
Polytel® APT (Access Point Terminal) Trade Name:
Physiological Measurement Tramitter and Receiver Common Name:
Classification: no: DRG
A. Predicate Devices:
The Polytel® APT is substantially equivalent to the following predicate devices:
| 510(k) number: | K041816 |
|---|---|
| Device Name: | RTX3320 Wireless Telehealth Gateway |
| Applicant: | RTX Healthcare |
B. Device Description:
The Polytel® APT device performs transmission of physiological patient information to and from wireless patient monitors and a remote data server healthcare facility over an encrypted dialup Internet connection. The APT, with its built-in telephone modem, transmits data over the public switched telephone network and the dial-up Internet.
The APT is contained in a small plastic unit, containing two standard telephone jacks for connection to standard phone outlets, a 5V power input jack for connection to an AC adapter, and four indicator lights. The indicator lights are used to show the reception of a measurement from a transmitting device, to show when the telephone line is in use, and to indicate if there has been an error (delay) in transmission.
Image /page/0/Picture/18 description: The image contains a black circle against a white background. The circle is solid black and appears to be centered in the frame. There are no other objects or details present in the image, making it a simple and minimalist composition.
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Two server-side components are involved in the operation of the APT, the first providing a centralized configuration database, the second providing for data collection and translation to a standard protocol.
The APT device is not used directly on a patient, nor attached electrically to any device that is used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.
C. Intended use and indications for use:
The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.
The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.
Any device certified by Polyman Wireless as compatible can use the Polytel® APT to forward its data.
The device is not intended for emergency calls, and may not be used to send any realtime alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.
The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient: alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.
A list of compatible devices and services will be available on the Polymap Wireless website.
D. Substantial Equivalence Summary:
The Polytel APT has the same fundamental scientific technology and intended use as the predicate devices (K041816, K080538).
E. Technological Characteristics:
The Polytel APT has technological characteristics that are very similar to those of the predicate devices, as all use Bluetooth technology and dial-up modems. All of these
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devices are line-powered, and each device uses the same frequency band of 2.402-2.480 GHz.
F. Testing:
The testing consisted of three types: bench testing using Polymap procedures and specifications; field testing under actual use conditions, and performance standards testing. The results were acceptable.
G. Conclusions
This pre-market submission has demonstrated substantial equivalence, as defined and understood in sections 513(0)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAY 2 4 2010
Polymap Wireless LLC c/o Mr. Pierre Landau, Ph.D. President 310 S. Williams Blvd. Ste. 350 Tucson, AZ 85711
Re: K100524
Device Name: Polytel® APT (Access Point Terminal) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (Two) Product Code: DRG Dated: February 10, 2010 Received: February 24, 2010
Dear Mr. Landau:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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. Pierre Landau, Ph.D.
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); medical device reporting (reporting of medical device-related adverse events).(21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K100524
Device Name: Polytel® APT
Indications For Use:
The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.
The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.
Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data.
The device is not intended for emergency calls, and may not be used to send any real-time alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.
The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient; alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.
A list of compatible devices and services will be available on the Polymap Wireless website.
AND/OR Over-The-Counter Use Prescription Use × X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device
510(k)
Devices (OIVD)
Division Sign-Off
510(k) Numbe
Division of Cardiovascular Devi
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).