(291 days)
The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies. The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.
The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.
The DeVilbiss 8650D Compressor is a medical device intended for use as an air source to operate a pneumatic nebulizer. The submission K963349 focuses on demonstrating its substantial equivalence to a predicate device, the Allied Healthcare/Timeter PCS414, rather than presenting a detailed study proving specific clinical acceptance criteria of the device itself through a diagnostic study.
The provided text describes basic performance testing to ensure the device functions as intended and meets safety standards. It does not contain information about a diagnostic study with human subjects, ground truth establishment, or expert reviews as typically found for AI/imaging devices.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|---|
| Pressure Output | Comparable to predicate device | Tested (result not specified) |
| Flow Output | Comparable to predicate device | Tested (result not specified) |
| Sound Pressure Level | Low noise level (qualitative) | Tested (result not specified) |
| Temperature Rise | Within safe operating limits | Tested (result not specified) |
| Shipping Performance | Device integrity maintained after shipping | Tested (result not specified) |
| Electrical Safety | Meet UL-544 Standard for Safety | Will meet UL-544 Standard |
| Electromagnetic Compatibility | Comparable to predicate device | Tested (result not specified) |
Note on Acceptance Criteria: The document primarily relies on the concept of "substantial equivalence" to the predicate device (Allied Healthcare/Timeter PCS414). Therefore, the implied acceptance criteria for performance metrics are that the DeVilbiss 8650D performs comparably to the predicate device in terms of pressure and flow output, sound level, temperature rise, and electrical safety. The specific numerical values for these criteria or the test results are not detailed in this 510(k) summary.
2. Sample Size for the Test Set and Data Provenance
This information is not available in the provided text. The testing described is for the device's physical and electrical performance, not a clinical study with a "test set" of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available as the submission does not describe a study involving expert review for establishing ground truth on patient data. The "testing" mentioned refers to engineering and safety tests of the compressor itself.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" in the context of diagnostic performance involving human or AI interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is a compressor, not a diagnostic imaging or AI-assisted interpretation tool. The submission is for substantial equivalence based on engineering and safety performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical compressor, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (a compressor) would be related to its engineering specifications and safety standards, rather than clinical outcomes or pathology.
- Engineering Specifications: For pressure and flow output, the ground truth would be the defined output characteristics of the predicate device and established engineering standards.
- Safety Standards: For electrical safety and temperature, the "ground truth" is compliance with recognized standards like UL-544.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, not "trained."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set.
Summary of Device Performance Testing from Section 4 of the 510(k) Summary:
The DeVilbiss 8650D was subjected to performance testing focusing on:
- Pressure and Flow Output: To ensure it can adequately drive pneumatic nebulizers.
- Sound Pressure Level: To confirm it operates at a low noise level as described.
- Temperature Rise: To ensure safe continuous operation.
- Shipping Performance: To ensure the device integrity is maintained during transportation.
- Electromagnetic Compatibility: To ensure it functions without interference and does not cause interference.
Agency Approvals / Standards:
The device is stated to meet the UL-544 Standard for Safety, Medical and Dental Equipment.
Conclusion stated in the 510(k):
The performance testing results did not indicate any safety and effectiveness concerns when compared to the predicate device, Allied Healthcare PCS 414, thus supporting the claim of substantial equivalence.
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510(k) SUMMARY STATEMENT
13 1501
Submitter:
DeVilbiss Health Care, Inc. 1200 East Main Street P.O. Box 635 Somerset, Pa 15501-0635 USA
Contact:
Matt Smith 814-443-7531 814-443-7571 FAX
| Date of 510(k) Submittal: | August 26, 1996 |
|---|---|
| Classification Name: | Pump, Nebulizer, Electrically Powered |
| Common Name: | Compressor used for nebulization and humidification |
| Proprietary Name: | 8650D |
| Equivalent to Device: | Allied Healthcare/Timeter PCS414 |
Description of Device:
The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.
Intended Use of Device:
The DeVilbiss 8650D is used with a pneumatic nebulizer to administer humidified air or medication into the airways to treat respiratory disorders. The device is intended for home health care and institutional use. Users of this device are adult and pediatric patients with tracheostomies or suffer from asthma, cystic fibrosis, and chronic obstructive pulmonary disease.
Performance Testing:
The DeVilbiss 8650D was tested for pressure and flow output, sound pressure level, temperature rise, and shipping performance.and he tromay ne fre compartibulity.
Agency Approvals:
The DeVilbiss 8650D will meet UL-544 Standard for Safety, Medical and Dental Equipment.
Conclusion:
The results of the above testing do not indicate any safety and effectiveness concerns as compared to the Allied Healthcare PCS 414.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Mr. Matt Smith DeVilbiss Health Care, Inc. 1200 East Main Street · ····· P.O. Box 635 Somerset, Pennsylvania 15501-0635
Re: %K963349 DeVilbiss 8650D Requlatory Class: II (two) Product Code: 73 BTI Dated: May 18, 1997 Received: May 19, 1997
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Matt Smith
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known):_ K963349
Device Name: DeVilbiss Health Care, Inc. 8650D Compressor
Indications For Use:
The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies.
The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Curtis A. Tinsdale
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
Prescription Use V (Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Format 1-2-96)
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.