(123 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to provide further clues.
No
The device measures physiological parameters (%SpO2 and heart rate) and does not provide therapy or treatment.
No
The device measures vital signs (%SpO2 and heart rate) for monitoring purposes, which is not stated as making a diagnosis.
Unknown
The provided summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes measuring %SpO2 and heart rate, which typically requires a sensor (hardware). Without a description of how these measurements are obtained, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure %SpO2 and heart rate. These are physiological measurements taken directly from the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
The Model 120 is a patient monitoring device, not a device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The Model 120 is intended to be used in the hospital, doctor's office, emergency medical facilities, or home care environments to measure %SpO2 and heart rate. The Model 120 is intended for use in short-term monitoring on adults and children.
Product codes
74 DQA
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
adults and children
Intended User / Care Setting
hospital, doctor's office, emergency medical facilities, or home care environments; physician, nurse, or medical technician.
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2000
Ms. Richella Goo Palco Laboratories 8030 Soquel Avenue Santa Cruz, CA 95062-2032
K994372 Re : Model 120 Regulatory Class: II (two) Product Code: 74 DQA March 28, 2000 Dated: March 30, 2000 Received:
Dear Ms. Goo:
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 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). 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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.
1
Page 2 - Ms. Richella Goo
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Joanna Whitaker-fee;
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | _ of _ |
|---|---|
| ------ | -------- |
: 15
| 510(k) Number (if known): | K994372 |
|---|---|
| Device Name: |
..............................................................................................................................................................................
Indications For Use:
PALCO Labs Model 120 Premarket Notification [510(k)] Submission
2.2 Intended Use -- Indications for Use Statement
The Model 120 is intended to be used in the hospital, doctor's office, emergency medical facilities, or home care environments to measure %SpO2 and heart rate.
The Model 120 is intended for use in short-term monitoring on adults and children.
The Model 120 will be operated by a physician, nurse, or medical technician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number__________
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use__________
(Optional Format 1-2at 1-2-96)