(15 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on a pneumatically powered ventilator.
Yes
The device is a ventilator, which is used to support or replace a patient's breathing, making it a therapeutic device.
No
The device is a ventilator, designed for patient ventilation, which is a therapeutic function, not a diagnostic one.
No
The device is described as a "pneumatically powered ventilator," which is a hardware device. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patient ventilation," which is a direct medical intervention on a patient's respiratory system.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Lack of IVD Keywords: The description does not mention any terms related to laboratory testing, samples, analysis of biological materials, or diagnostic purposes in the context of analyzing samples.
Therefore, the babyPAC pneumatically powered ventilator is a medical device used for patient support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation in the pre-hospital and alternative site arenas.
Product codes
73 CBK
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical caregivers, paramedics and other trained personnel / pre-hospital and alternative site arenas
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(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 § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that resemble a human form or a stylized representation of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 1999
Mr. Norman Gray President pneuPAC Incorporated 814 Farkway Broomall, PA 19008
Re: K970158 BabyPac Regulatory Class: II (two) Product Code: 73 CBK Dated: September 27, 1997 April 14, 1998 Received:
Dear Mr. Gray:
This letter corrects our substantially equivalent letter of This Ietter corrects our subscantially ogar letter identified the April 28, 1998, regarding the Babyrac, the correct product code is product code as 73 MWT. Informal of the tracking section of this letter.
We have reviewed your Section 510 (k) notification of intent to market. We have reviewed your section sion) hoseasonined the device is the device referenced above and we have tor use stated in the substantially in substantially equivatent ((ros- modicate devices marketed in enclosure)] to legally marketed produced the enactment date of the interstate comments or to devices that have been reclassified in Medical Device Amendments of to device charal Food, Drug, and Cosmetic accordance with the provisions on the the device, subject to the Act (Acc). Tourmaly, cheres of the Act. The general controls general concrors provisions e equirements for annual registration, provisions of the Act Include Loguing practice, labeling, and rrohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special If your device Is classified (See annoyal) it may be subject to such Controls) of Class III (Fremarket hpprovulations affecting your device additional Collects. Existing major and Regulations, Title 21, Parts 800 can be round in the code of readers no assumes compliance co 695. A sabscurities progetactive requirements, as set forth in the with the Good Mandractaring Frace Mcdical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with inspections, I be wire vesult in regulatory action. In addition, the
1
Page 2 - Mr. Norman Gray
Food and Drug Administration (FDA) may publish further announcements Food and Drug American (17), Rogister. Please note: this concerning your device int notification submission does not affect any response to your premarked inder sections 531 through 542 of the Act obligation you might have under sections our charing and one of the provisions, or other Federal laws or regulations.
on August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Mcdical that under Section 319(e) of the not as the above device as a device bevices acc of 1990, ThA hab race the device is subject to tracking, which required to adopt a method of tracking that follows the you are required to adopt a meense an and then identifies and follows
devices through the distribution chain moguiremoves of the devices chrough the discribution on and in the provirements of the the patients who receive them. Inc. Inc. Seescribed in the August 16, 1993
regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to continue marketing your device as This fected will allow you to concenterial in the FDA finding of described in your from promarios to a legally marketed predicate substancial equivalence of joing for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advicand additionally 809.10 for in xitre regulation (21 Crk Fare over and and the Office of Compliance at (1) 594–4648. Additionally, for questions on the promotion and (101) 33 4040. "Addressed please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities (301) 394-4659. Ocher general from the Division of Small Manufacturers
under the Act may be obtained from the comments of any of Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ath. A. Carlowsh.
J. Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Officc of Device Evaluation Center for Devices and Radiological Health
2
Page 1 of 1
510(k) Number (if known): K970158
babyPAC Device Name:
Indications for Use:
The babyPAC pneumatically powered ventilator is specifically designed for use by qualified
the success in a securities and other trained personel for patient ventilation The babyPAC pheumatics and other trained personnel for patient ventilation
medical caregivers, paramedics and other trained personnel for patilation medical caregivers, paramedics and other trained percurities for pro-hospital and alternative site arenas.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number