(283 days)
The Packet Decoder Process (PDP) is indicated for use as a prescription software device to receive MDDS digital data packets and decode, collate and deliver data to a Class I, MDDS, Enterprise Service Bus according to a proprietary scheme defined by Zephyr Technology.
The Packet Decoder Process (PDP) receives digital data that is transmitted by BioHarness 3.0, K 1 1 3045 in a proprietary structure. PDP receives this complex array of packet coded data. A decoding scheme is used to decode data and organize for presentation and access by Class I MDDS devices. The Packet Decoder Process is manufactured by Zephyr Technology Corporation. This software is loaded and executed in an MDDS operating systems in an MDDS computer. This complex process is defined by a proprietary scheme: Zephyr's General Comms Link Specification.
The provided text describes the Packet Decoder Process (PDP) device and its intended use but does not contain a study demonstrating its performance against specific acceptance criteria. The document states that "A series of factory tests are conducted to verify the intended signals are accurate and can maintain calibration over its useful life," and that the device "has benefited from design, development, testing and production procedures that conform to Quality Systems." However, specific details of these tests, including acceptance criteria and results, are not provided in the given text.
Therefore, many sections of your request cannot be fulfilled due to the lack of detailed performance study information in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
Not provided in the document. The document mentions "factory tests" to verify intended signals are accurate and maintain calibration but does not specify the acceptance criteria or the results of these tests.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document. The document refers to "a series of factory tests" but does not mention the sample size used, the specific data tested, or its provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not provided in the document. The device is a software for decoding digital data packets (Packet Decoder Process, PDP). Its function is to accurately decode and collate data according to a proprietary scheme. This type of device typically relies on factory testing against known inputs and expected outputs, rather than expert-established ground truth in the way medical image analysis or diagnostic AI systems might. The document does not mention any expert involvement in establishing ground truth for testing.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document. Given the nature of the device as a data decoder, an adjudication method (like 2+1, 3+1) used for interpreting ambiguous medical cases is not relevant or mentioned. Performance testing would likely involve comparing decoded data against pre-defined correct decodings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not provided in the document. The PDP is a standalone software component for decoding digital data and delivering it to a Medical Device Data System (MDDS). It is not an AI-assisted diagnostic tool designed to improve human reader performance, so an MRMC study is not relevant.
6. Standalone Performance Study
The document implies that standalone testing was conducted as part of "factory tests" to verify accuracy and calibration. It states, "A series of factory tests are conducted to verify the intended signals are accurate and can maintain calibration over its useful life." However, no specific study details, metrics, or results are provided.
7. Type of Ground Truth Used
Not explicitly stated, but inferred: For a data decoding device, the ground truth would typically be the correctly decoded data as defined by the "proprietary scheme: Zephyr's General Comms Link Specification." The "factory tests" would involve feeding known, pre-encoded data into the PDP and verifying that the output matches the expected decoded values according to the specification.
8. Sample Size for the Training Set
Not applicable/Not provided in the document. The PDP functions by executing programmed commands written in Java based on a defined proprietary scheme. It is not an AI/ML model that requires a "training set" in the conventional sense for learning patterns.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document. As stated above, this is not an AI/ML device that requires a training set. Its function is deterministic, based on a predefined decoding algorithm.
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5. 510(k) Summary
K122763 JUN 2 0 2013
(per 21 CFR 807.92)
19 June 2013 Consultant Sponsor . Mr. Richard Keen Mr. Sailor Mohler Compliance Consultants Quality Manager 1151 Hope Street Zephyr Technology Corporation Stamford, CT 06907-1659 1 Annapolis Street, Suite 200 203 329 2700 F 203 329 2345 Annapolis MD 21401 USA rkeen@fda-complianceconsultants.com Office: 443-569-3603 sailor.mohler@zephyranywhere.com
| Proprietary Name: | Packet Decoder Process (PDP) |
|---|---|
| Common Name: | PDP |
| Device Classification Name: | Transmitters and receivers, physiological signal, radiofrequency |
| Classification Number: | 21 CFR 870.2190 |
| Product Code | DRG |
| Reviewing Group | Cardiovascular |
| Device Classification | Class II |
| Establishment registrationNo. | # 233836 |
| Predicate Device | PDP is substantially equivalent to three predicates determinedsubstantially Equivalent in K113045, BioHarness 3.1) Firmware (9500.0085). The PDP is a mirror image of theportion of the firmware (PEP) that implements the encoding ofdigital data.2) Test Application (9500.0091). The PDP performs the samefunction as the Test Application to decode packet data andplaces the decoded data in registers for MDDS access.3) Config Tool (9500.0096). The PDP performs the samefeatures / functions as the Config Tool (9500.0096) to changethreshold alert settings in the hardware resisters in the |
Trademark Notice: All Trademarks used other than those of Zephyr Technology Corporation are registered to their respective owners.
Device Description
The Packet Decoder Process (PDP) receives digital data that is transmitted by BioHarness 3.0, K 1 1 3045 in a proprietary structure. PDP receives this complex array of packet coded data. A decoding scheme is used to decode data and organize for presentation and access by Class I MDDS devices.
The Packet Decoder Process is manufactured by Zephyr Technology Corporation. This software is loaded and executed in an MDDS operating systems in an MDDS computer. This complex process is defined by a proprietary scheme: Zephyr's General Comms Link Specification.
INDICATIONS FOR USE
The Packet Decoder Process (PDP) is indicated for use as a prescription software device to receive MDDS digital data packets and decode, collate and deliver data to a Class I, MDDS, Enterprise Service Bus according to a proprietary scheme defined by Zephyr Technology.
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- 510(k) Summary
(per 21 CFR 807.92)
INTENDED USE
The BioHarness 3-M1 Packet Decoder Process (PDP) is intended for decoding digital data packets that were coded in the BioHarness 3.0 Packet Encoder Processor (PEP). The decoding process receives data from an MDDS data transmission system then decodes, collates and drives MDDS registers on the Enterprise Service Bus. This process is defined by the proprietary scheme: Zephyr's General Comms Link Specification, version 1.44 dated 11 June 2009 Part Number #9700.0028 (and subsequent revisions).
The scientific concept on which this device is based is the principle that complexity and precise structure of packet data give rise to a repeatable mechanism to "pack up" digital data and transmit it using a qualified communication system. At the receive side, a scheme decodes or "un-pack" this data and delivers it to MDDS registers. This device functions by executing programmed commands written in the Java language. The calibration is established by the factory and yields accurate and calibrated signals that can maintain calibration over its useful life.
Substantial Equivalence
Zephyr Technology Corporation has determined that the Packet Decoder Process (PDP) is substantially equivalent to the performance to the predicate device. The differences between these systems are incidental and not significant. Both this device and the predicates use a similar technological characteristics and principles.
Safety and Effectiveness
This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. A series of factory tests are conducted to verify the intended signals are accurate and can maintain calibration over its useful life. The Packet Decoder Process (PDP) has benefited from design, development, testing and production procedures that conform to Quality Systems.
Zephyr Technology Corporation continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting device to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
K122763
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three distinct head-like shapes, suggesting multiple individuals or a sense of community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" curving along the left side and "USA" positioned at the top right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
Zephyr Technology Corp. c/o Richard Keen 1151 Hope St Stamford, CT 06907
Re: K122763
Trade/Device Name: Packet Decoder Process (PDP) Regulation Number: 21 CFR 870.2190 Regulation Name: Transmitters and receivers, physiological signal, radiofrequency Regulatory Class: Class II Product Code: DRG Dated: February 18, 2013 Received: April 25, 2013
Dear Mr. Keen:
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.
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
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Page 2 - Mr. Richard Keen
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and. Radiological Health
Enclosure
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4. Indications for Use Statement
510(K) Number assigned K 122763 Name: Packet Decoder Process (PDP)
INDICATIONS FOR USE
The Packet Decoder Process (PDP) is indicated for use as a prescription software device to receive MDDS digital data packets and decode, collate and deliver data to a Class I, MDDS, Enterprise Service Bus according to a proprietary scheme defined by Zephyr Technology.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | XXX |
|---|---|
| or | |
| Over - The - Counter Use | (Per 21 CFR 801.109) |
| (Optional Format 1-2-96) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S 2013.06.20 16:07:44 1 -04'00'
Page 1 of 1
§ 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).