(85 days)
Not Found
No
The summary describes a standard pulse oximeter with basic monitoring functions and data output capabilities, with no mention of AI or ML.
No
The device is a pulse oximeter for monitoring physiological parameters, not for treating a disease or condition.
No
Explanation: The device is described as a pulse oximeter for continuous monitoring of patient SpO2, pulse rate, and pulse strength measurements. It provides measurements of physiological parameters but does not interpret those measurements to diagnose a condition.
No
The device description clearly outlines hardware components such as an LCD display, keypad, LED, and infrared serial port, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, the BCI 3180 pulse oximeter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the BCI 3180 clearly states it is used for "continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements." This involves direct measurement on the patient, not analysis of a sample taken from the patient.
- The intended use and device description focus on monitoring physiological parameters directly from the patient. There is no mention of collecting or analyzing biological samples like blood, urine, or tissue.
Therefore, the BCI 3180 pulse oximeter falls under the category of a medical device used for patient monitoring, but not an IVD.
N/A
Intended Use / Indications for Use
The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally marketed by BCI, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an SpO2 sensor interface, display of patient and waveform data via an LCD display, power status LED, and the function keypad area consisting of six keys (on/off, waveform / trend, alarm audio pause/off, menu / enter, up arrow & down arrow). The monitor has an infrared serial port that is used for data communications to a printer and can download trend data to a printer of personal computer through connection to the SpQ2 sensor interface (sensor must be removed from the device).
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
all patients from neonate to adult.
Intended User / Care Setting
hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home.
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)
The design of this device utilizes currently available technology found in legally marketed devices. The BCI 3180 Pulse Oximeter is a redesign of the BCI 3100 Pulse Oximeter. The new design uses currently available parts, meet the most recent product standards, and has a more up-to-date case and display. Testing was done to ensure that the BC1 3180 Pulse Oximeter would perform safely and accurately within the environment(s) for which it is to be marketed.
Safety and environmental testing was conducted in accordance with the Reviewer’s Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrate that the BCI 3180 pulse oximeter is in compliance with the guidelines and standards referenced in the reviewer’s guides and that it performs within its specifications and functional requirements.
Testing of device performance included clinical testing of the SpO» parameter and overall software validation. The results demonstrated that the BCI 3180 pulse oximeter performed within its specifications.
The testing described above indicates that there is no functional difference between the operation of the BCl 3180 pulse oximeter and the predicate device. Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
BCI 3100 Pulse Oximeter (K893877), BCI 3304 Pulse Oximeter (K962156), BCI 3401 Pulse Oximeter (K980714)
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
Image /page/0/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle on the left side that is filled with vertical lines. To the right of the circle are the letters "BCI" in a bold, sans-serif font. There is a registered trademark symbol in the upper right corner of the logo.
APR 3 0 2002
BCI, Inc.
N7 W22025 Johnson Road Waukesha, WI 53186-1856 USA Tel: 262-542-3100 Fax: 262-542-3325 www.smiths-bci.com
Summary of Safety and Effectiveness
Submitter: Address:
Telephone:
Contact:
Prepared:
BCI. Inc. N7 W22025 Johnson Road Waukesha, WI 53186
(262) 542-3100
VP Requlatory Affairs
January 30, 2002
BCI 3180 Pulse Oximeter
Common/Classification Name:
Predicate Devices:
Proprietary Name:
Pulse Oximeter
BCI 3100 Pulse Oximeter (K893877) BCI 3304 Pulse Oximeter (K962156) BCI 3401 Pulse Oximeter (K980714)
New Device Description:
The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally marketed by BCI, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an SpO2 sensor interface, display of patient and waveform data via an LCD display, power status LED, and the function keypad area consisting of six keys (on/off, waveform / trend, alarm audio pause/off, menu / enter, up arrow & down arrow). The monitor has an infrared serial port that is used for data communications to a printer and can download trend data to a printer of personal computer through connection to the SpQ2 sensor interface (sensor must be removed from the device).
smiths Smiths Medical - a part of Smiths Group pla
1
Image /page/1/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle on the left side that is filled with vertical lines. To the right of the circle are the letters BCI in bold, sans-serif font.
Intended Use:
The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BC1 pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.
Performance Data:
The design of this device utilizes currently available technology found in legally marketed devices. The BCI 3180 Pulse Oximeter is a redesign of the BCI 3100 Pulse Oximeter. The new design uses currently available parts, meet the most recent product standards, and has a more up-to-date case and display. Testing was done to ensure that the BC1 3180 Pulse Oximeter would perform safely and accurately within the environment(s) for which it is to be marketed.
Safety and environmental testing was conducted in accordance with the Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing have been completed. The results demonstrate that the BCI 3180 pulse oximeter is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements.
Testing of device performance included clinical testing of the SpO» parameter and overall software validation. The results demonstrated that the BCI 3180 pulse oximeter performed within its specifications.
The testing described above indicates that there is no functional difference between the operation of the BCl 3180 pulse oximeter and the predicate device. Based on these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
2
Image /page/2/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle with vertical lines and two horizontal lines going through the middle. To the right of the circle are the letters BCI in bold black font.
Respectfully,
Donald Aliyant
Donald Alexander VP Regulatory Affairs
BCI is a trademark of BCI, Inc. The symbol ® indicates it is registered in the U.S. Patent and Trademark Office and certain other countries,
smiths Smiths Medical - a part of Smiths Group ple
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2002
Mr. Donald Alexander BCI, Inc. N7 W22025 Johnson Road Waukesha. WI 53186
Re: K020350
BCI 3180 Pulse Oximeter Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: January 30, 2002 Received: February 4, 2002
Dear Mr. Alexander:
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. Donald Alexander
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 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Martin
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if Known): Ko20350
Device Name: BCI 3180 Pulse Oximeter
Indications For Use:
Intended Use:
The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
월 11시 선보 서부 전 노선 서 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대 대
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K020350