MODEL 120

K994372 · Palco Labs, Inc. · DQA · Apr 28, 2000 · Cardiovascular

Device Facts

• Record ID: K994372
• Device Name: MODEL 120
• Applicant: Palco Labs, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Apr 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended 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. The Model 120 will be operated by a physician, nurse, or medical technician.

Device Story

Model 120 is a pulse oximeter for short-term monitoring of %SpO2 and heart rate; used in hospitals, clinics, emergency facilities, or home care; operated by physicians, nurses, or medical technicians; provides real-time physiological measurements to assist clinical decision-making.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Pulse oximetry device for measuring %SpO2 and heart rate; intended for short-term monitoring; form factor suitable for clinical and home environments.

Indications for Use

Indicated for short-term monitoring of %SpO2 and heart rate in adults and children in hospital, clinical, emergency, or home care settings.

Regulatory Classification

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.

Submission Summary (Full Text)

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 | <div style="display:inline-block;">✓</div> |
|----------------------|--------------------------------------------|
| (Per 21 CFR 801.109) | |

OR
Over-The-Counter Use__________
(Optional Format 1-2at 1-2-96)