(241 days)
Not Found
No
The summary describes a standard pulse oximeter and does not mention any AI or ML capabilities. The performance study focuses on the correlation between blood gas and oximetry readings, which is a standard metric for this type of device.
No
The device measures physiological parameters (% SpO2, pulse rate, and pulse indication) for spot-checking, but it does not treat or prevent a medical condition.
Yes
The device measures % SpO2 and pulse rate, which are physiological parameters used to assess a patient's health status, aligning with the definition of a diagnostic device. Its intended use as a "spot-check device" in clinical environments further supports its diagnostic function.
No
The device description explicitly states it is a "portable, lightweight, and battery-operated device that measures %SpO2 and pulse rate on the finger of a patient," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- This device's function: The Finger Pulse Oximeter measures % SpO2 and pulse rate by shining light through the finger and detecting the absorption of that light. This is a non-invasive measurement performed on the body, not on a specimen taken from the body.
Therefore, based on the provided information, the Finger Pulse Oximeter is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Finger Pulse Oximeter is a small portable device that measures % SpO2, pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The AccuPulse Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 and pulse rate on the finger of a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger
Indicated Patient Age Range
pediatric patients weighing 35 lbs or more, and on adult patients.
Intended User / Care Setting
home or clinical environment
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)
A clinical study was sponsored by ITEC Engineering, LLC, represented by Daniel Englert and Eugene Palatnik. This clinical study was performed at the Milwaukee VA Medical Center. Anesthesia Research Lab. The clinical data was collected in April 2005. This clinical study showed that the correlation between blood gas and oximetry readings, calculated statistically, is 1.87%, which is well within the target accuracy of not more than 2.0%. This clinical study was performed using prototype devices that lead to the final finished device known as the Fox Oximeter device, which is legally marketed by Biotran, Inc.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation between blood gas and oximetry readings, calculated statistically, is 1.87%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
1. Submitter's Identification:
Applicant:
Lawrence Pellerito, Principal 3101 West Thomas Road, Suite 108 Phoenix, AZ 85017 Tel: 602-272-2141 Fax: 602-272-1275
MAY 1 1 2007
James A. Dunning, President Correspondent: QualPro Consulting, LLC 537 N. Spencer Mesa, AZ 85203 Tel: 480-703-3631 Fax: 480-461-1961
Date:
11 May 2007
Device Name: 2.
| Trade Name: | AccuPulse Oximeter |
|---|---|
| Common Name: | Finger Pulse Oximeter |
| Classification Name: | Oximeter |
Predicate Device Information: 3.
The legally marketed device to which the submitter claims equivalence is:
Fox Oximeter (K051736)
.4. Device Description:
The AccuPulse Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 and pulse rate on the finger of a patient.
Indications for Use: 5.
The Finger Pulse Oximeter is a small portable device that measures % SpO2 pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.
6. Comparison with Predicate Device:
Both the AccuPulse Pulse Oximeter and the Fox Oximeter are designed to monitor %SpO2 and pulse rate. The same critical components and component sources are used for both the Fox Oximeter and the AccuPulse Pulse Oximeter. The AccuPulse Pulse Oximeter uses a circular Light Emitting Diode (LED) indicator to show that the battery is on. The Fox Oximeter does not have a specific battery on indicator, at least one LED will be on at all times, indicating power is on.
Testing was done to ensure that the AccuPulse Pulse Oximeter would perform safely and effectively within the environment(s) for which it is to be marketed.
5/11/2007 Page 1 of 3
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7. Discussion on Non-Clinical Test Performed:
The AccuPulse Oximeter complies with the following:
- EN 50082-1 .
- EN 61000-4-2 ●
- EN 61000-4-3 .
- . EN 61000-4-8
- . EN 55022-1998 with Amendment A1;2000 (CISPR-22)
The following studies were performed on the Elastosil® E 951 (previously known as Elastosil® SWS 951) Control No: 27943 SE material, by BIOSERVICE, Scientific Laboratories GmBH, Munich, BehringStrasse 6, D-82152 Planegg:
- . Cytotoxicity
- . Hemolysis
- . Pryogenicity
- . Sensitization
- Dermal Irritation .
- Implantation (90 days) .
The following studies were performed on the Dow Corning® C6-550 Liquid Silicone Rubber, as described in Dow Corning's "SUMMARY OF QUALIFICATION DATE FOR DOW CORNING ® C6-550 LIQUID SILICONE RUBBER, Revision Date REC 01 Aug 2003":
- . Acute Toxicity
- . Systemic Toxicity
- Intracutaneous Reactivity �
- . 30-Day Implant
8. Discussion on Clinical Test Performed:
A clinical study was sponsored by ITEC Engineering, LLC, represented by Daniel Englert and Eugene Palatnik. This clinical study was performed at the Milwaukee VA Medical Center. Anesthesia Research Lab. The clinical data was collected in April 2005. This clinical study showed that the correlation between blood gas and oximetry readings, calculated statistically, is 1.87%, which is well within the target accuracy of not more than 2.0%. This clinical study was performed using prototype devices that lead to the final finished device known as the Fox Oximeter device, which is legally marketed by Biotran, Inc.
ACCUPULSE COMPANY worked with ITEC Engineering, LLC, to establish ACCUPULSE COMPANY as a separate owner/operator to manufacture the pulse oximeter device. ITEC Engineering, LLC and Biotran, Inc. granted ACCUPULSE COMPANY permission to use the components, component sources, and clinical study records originally established for the Fox Pulse Oximeter. ITEC Engineering, LLC, currently programs and supplies the microprocessor and the associated signal processing software (FOX V1.03) for the Fox Finger Pulse Oximeter. ITEC Engineering, LLC, has also programmed and supplied the microprocessor and the associated signal processing software (AccuPulse V1.03) to ACCUPULSE COMPANY for the AccuPulse Pulse Oximeter.
5/11/2007 Page 2 of 3
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9. Conclusion:
The AccuPulse Pulse Oximeter (subject device) has the same intended use and theory of operation as the Fox Oximeter (predicate device). Moreover, the critical components and the same component sources are used for both devices. Only minor display differences differentiate the AccuPulse Pulse Oximeter from the predicate device, the Fox Pulse Oximeter. The technological characteristics of the AccuPulse Pulse Oximeter are the same technological characteristics employed by the Fox Pulse Oximeter. The minor display differences do not affect safety or effectiveness of the AccuPulse Oximeter for its intended use. Therefore, the AccuPulse Pulse Oximeter is substantially equivalent to the Fox Oximeter (predicate device).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" in capital letters. The text is arranged around the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2007
Eagle Medical Equipment Compamy C/O Mr. James A. Dunning President QualPro Consulting, LLC 537 N. Spencer Mesa, Arizona 85203
Re: K062724
Trade/Device Name: AccuPulse Pulse Oximeter Model OX1A Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 30, 2007 Received: May 1, 2007
Dear Mr. Dunning:
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.
4
Page 2 - Mr. Dunning
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 forth in the quality systems (QS) 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 vour 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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ACCUPULSE COMPANY
Indications for Use
510(k) Number (if known):
Device Name: AccuPulse Finer Pulse Oximeter
Indications For Use: The Finger Pulse Oximeter is a small portable device that measures % SpO2, pulse rate, and pulse indication on the finger. It may be used as a spot-check device in the home or clinical environment. The pulse oximeter will provide reliable measurements on pediatric patients weighing 35 lbs or more, and on adult patients. This device is not intended for continuous patient monitoring. There are no audible or visible patient alarms.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ch. Uffo
non orgh-Off) ിന്നാം വ്യസ-ാനി
Hospital of Anesthesiology, General Hospital, Control, Dental Devices
062724
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