(212 days)
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery, ICU).
The PW820 is operated at a fixed skin surface temperature setting of either 41°C or 37°C. The setting of 41°C is intended for adult patients under general anesthetic. The setting of 37℃ is intended for pediatric and infant patients and for non-anesthetised adults.
The PW820 is for use with infants only during surgery.
The PW820 Surgical Patient Warmer consists of a heater assembly and controller unit, with mounting pole and base sections. The heater assembly includes a single rod infrared heating element housed inside a parabolic reflector. Two spotlights (designed to set the distance of the heater from the patient) are mounted at the back of the heater assembly. The heater assembly can be swung either side of the warmer, away from the patient, or rotated through ± 90° along the patient axis. A metal grill on the underside of the heater prevents contact with the heating element.
The controller unit supports the heater assembly, and contains the device electronics, control panel and labels. The front panel contains the control buttons, temperature display, main power switch and temperature sensor socket. Controls include temperature selection and positioning spotlight operation. LED displays include indicators for set temperature, alarms, positioning spotlights, heater power, and a 3digit skin temperature display. The main label is located on the controller rear panel. and the power socket is mounted in the underside of the controller.
A single pole mounting system supports the controller unit, with two sections of stainless steel tubing providing height adjustment. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with castors which include foot-operated brake levers.
Accessories for the PW820 include 'Reusable' and 'Single Use' skin temperature sensor probes, cord tidy, I.V. pole and bag hook.
When switched on, with the desired temperature selected and sensor positioned correctly on the patient, the PW820 provides stable control of skin temperature by automatically adjusting the heater power to compensate for varying metabolic and environmental conditions. Audible and visual alarms alert the user to high/low temperature situations, faults and power failure. Independent safety features are included to control maximum output and avoid thermal injury to the patient.
Here's an analysis of the provided 510(k) summary, aiming to extract information about acceptance criteria and the supporting study, formatted as requested.
It's important to note that the provided document is a 510(k) summary for a medical device (a patient warmer), not a submission for an AI/ML powered device. Therefore, many of the requested fields related to AI-specific testing (e.g., test set, ground truth experts, MRMC studies, training set) are not applicable and thus cannot be populated from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device and compliance with general medical device standards.
Acceptance Criteria and Device Performance for Fisher & Paykel Healthcare PW820 Surgical Patient Warmer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Safety & EMC | IEC 60601-1 (Medical Electrical Equipment) | Device meets the requirements of the standards. |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Device meets the requirements of the standards. | |
| UL 2601-1 (US deviations for IEC 60601-1) | Device meets relevant deviations. | |
| Functional Safety | Independent safety features to control maximum output and avoid thermal injury. | Included and function as designed. |
| Efficacy in Warming | At least as effective as a forced air warming blanket in maintaining patient temperature intra-operatively and during recovery. | Clinical trial results showed the PW820 was "at least as effective as the warming blanket in maintaining patient temperature during both surgery and the recovery period." |
| Design & Performance Functional Requirements | (General, implied by engineering and non-clinical tests) | Testing indicates it meets design and performance functional requirements. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "a randomized, controlled trial" but does not specify the number of patients included in this clinical test.
- Data Provenance: Not explicitly stated, but clinical tests were conducted for market approval in the US, so it’s likely data was collected in a country with recognized clinical research standards (e.g., US, New Zealand, etc.). The study was a prospective randomized, controlled trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a medical device (patient warmer) validation, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" in this context is patient temperature, measured objectively.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, the "test set" (clinical trial) involved objective measurement of patient temperature, not subjective assessments requiring expert adjudication.
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 Applicable. This is not an AI-powered device. The clinical study compared the device (PW820) to a competitor (forced air warming blanket), not human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm, but a standalone physical medical device. The clinical study evaluated its performance as a standalone warmer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The primary "ground truth" for the clinical study was objective patient temperature measurements, specifically core body temperature, and potentially skin surface temperature (given the device's function). This is a direct physiological outcome, not based on expert consensus, pathology, or subjective interpretation.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.
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Image /page/0/Picture/0 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font, with an ampersand between the two words. A horizontal line underlines the words. The word "HEALTHCARE" is on the second line in a similar font, but slightly smaller.
MAR 0 6 2003
15 Maurice Paykel Place Fast Tamaki P O Box 14 348, Panmure Auckland, New Zealand
Telephone: +64 9 574 0100 Facsimile: +64 9 574 0158 Website: www.fphcare.com
31 July, 2002
510(k) Summary of Safety and Effectiveness Information
Model No. / Name: PW820 Surgical Patient Warmer Classification Name: Infrared Lamp - 89 ILY Physical Medicine Devices, 21 CFR §890.5500 (Class II)
Fisher & Paykel Healthcare PW810 Patient Warmer, K982636 Predicate Device: Classification Name: Infrared Lamp - 89 ILY Physical Medicine Devices, 21 CFR §890.5500 (Class II)
(a)(1) - (a)(3) (refer to information above and concluding this summary) (a)(4) Description of the Device
The PW820 Surgical Patient Warmer consists of a heater assembly and controller unit, with mounting pole and base sections. The heater assembly includes a single rod infrared heating element housed inside a parabolic reflector. Two spotlights (designed to set the distance of the heater from the patient) are mounted at the back of the heater assembly. The heater assembly can be swung either side of the warmer, away from the patient, or rotated through ± 90° along the patient axis. A metal grill on the underside of the heater prevents contact with the heating element.
The controller unit supports the heater assembly, and contains the device electronics, control panel and labels. The front panel contains the control buttons, temperature display, main power switch and temperature sensor socket. Controls include temperature selection and positioning spotlight operation. LED displays include indicators for set temperature, alarms, positioning spotlights, heater power, and a 3digit skin temperature display. The main label is located on the controller rear panel. and the power socket is mounted in the underside of the controller.
A single pole mounting system supports the controller unit, with two sections of stainless steel tubing providing height adjustment. The lower pole section is mounted into a stabilizer weight attached to a five-arm base unit, with castors which include foot-operated brake levers.
Accessories for the PW820 include 'Reusable' and 'Single Use' skin temperature sensor probes, cord tidy, I.V. pole and bag hook.
When switched on, with the desired temperature selected and sensor positioned correctly on the patient, the PW820 provides stable control of skin temperature by automatically adjusting the heater power to compensate for varying metabolic and environmental conditions. Audible and visual alarms alert the user to high/low temperature situations, faults and power failure. Independent safety features are included to control maximum output and avoid thermal injury to the patient.
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(a)(5) Statement of the Intended Use
The Fisher & Paykel Healthcare PW820 device is an Infra-red Lamp, as per 21 CFR §890.5500. It emits energy at infra-red frequencies to provide topical heating, and is used to provide thermal support for anesthetized patients (who are susceptible to undesirable heat loss) undergoing surgical treatment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery).
(a)(6) Technological Characteristics Summary
The PW820 is derived from the PW810 Patient Warmer. Changes incorporated into the PW820 consist of converaing twin LED spotlights for determination of heater-topatient distance, a closer heater-to-patient distance, adjustable heater angle via a swivel joint, a shorter base stem, minor software changes and modified labeling and operating instructions. These changes do not affect substantial equivalence to the PW810. The overall design, materials, energy source and performance of the PW820 are the same as the PW810.
(b)(1) Discussion of the Non-Clinical Tests
The PW820 has been fully tested to the IEC 60601-1 and IEC 60601-1-2 medical electrical and EMC standards. The device meets the requirements of the standards. and the deviations relevant to the USA in UL 2601-1. The safety and effectiveness of the height positioning LED spotlight system has also been tested.
(b)(2) Discussion of the Clinical Tests
A randomized, controlled trial compared the efficacy of the PW820 with that of a forced air warming blanket in providing intra-operative warming for patients undergoing laparoscopic cholecystectomy surgery. The results showed that the PW820 was at least as effective as the warming blanket in maintaining patient temperature during both surgery and the recovery period.
(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance
The testing carried out for the PW820 Patient Warmer indicates that it meets design and performance functional requirements. Clinical verification studies demonstrate the successful use of the warmer and its ability to provide safe effective patient The proposed device meets the requirements of international and US warming. medical electrical equipment standards for safety.
signed:
Robert Petty
Robert Petry Fisher & Paykel Healthcare Ltd
te: 31 July 2002
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that represents the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 6 2003
Mr. Robert Petry Regulatory Affairs Engineer Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place, East Tamaki P.O. Box 14 348. Panmure Auckland, New Zealand
Re: K022609
Trade/Device Name: Surgical Patient Warmer PW820 JHU Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: December 3, 2002 Received: December 6, 2002
Dear Mr. Petry:
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.
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
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Page 2 - Mr. Robert Petry
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. 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 (301) 594-4659. 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 vours.
sincerely yours,
R. Mark N Milbern
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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Premarket Notification [510(k)] Number: K022609
3 March 2003
Fisher & Paykel Healthcare PW820 Surgical Patient Warmer
PREMARKET NOTIFICATION 510(k) INDICATIONS FOR USE STATEMENT
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery, ICU).
The PW820 is operated at a fixed skin surface temperature setting of either 41°C or 37°C. The setting of 41°C is intended for adult patients under general anesthetic. The setting of 37℃ is intended for pediatric and infant patients and for non-anesthetised adults.
The PW820 is for use with infants only during surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Malkezer
Division of General, Restorative and Neurological Devic
510(k) Number K022604
Prescription Use (Per 21 CFR §801.109)
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.