(322 days)
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
The OX201 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital. The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, use it very easy. Principle of the fingertip pulse oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant dada is shown on the Oximeter's display through electronic circuits and a microprocessor.
The document provided is a 510(k) summary for a Pulse Oximeter (Model: OX201). It primarily focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing. However, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets these criteria for a typical AI/ML medical device.
The provided document describes a traditional medical device (pulse oximeter) that relies on established physical principles for measurement, not an AI/ML device that requires a test set, ground truth established by experts, or MRMC studies.
Therefore, I can only provide information based on what is available in the document, which pertains to the performance of a pulse oximeter and its validation against established standards for non-AI devices.
Here's an attempt to answer your questions based on the provided text, highlighting where the information is not applicable for a traditional medical device like a pulse oximeter or is missing from the document:
Acceptance Criteria and Device Performance Study (Pulse Oximeter OX201)
The device, a Pulse Oximeter (Model: OX201), is a non-invasive device intended for spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Its performance is evaluated against recognized international standards for pulse oximeters, particularly ISO 80601-2-61.
1. Table of Acceptance Criteria and Reported Device Performance:
For a pulse oximeter, acceptance criteria typically relate to the accuracy of SpO2 and pulse rate measurements within specified ranges.
| Acceptance Criteria (Standard / Limit) | Reported Device Performance |
|---|---|
| SpO2 Accuracy | |
| ISO 80601-2-61: 2017 | Accuracy of SpO2: 70%-100%, ±2%; Less than 70% no definition. (Note: This matches the predicate device's accuracy specification.) |
| SpO2 Measurement Range | 70-100% |
| SpO2 Resolution | 1% |
| Pulse Rate Accuracy | |
| ISO 80601-2-61. Clause 201.12.1.104 | Accuracy of pulse rate: ±2bpm or ±2% (whichever is greater). (Note: This meets the requirements defined in the specified clause and matches the predicate device.) |
| Pulse Rate Measurement Range | 25-250bpm |
| Pulse Rate Resolution | 1 bpm |
| Biocompatibility | Complies with ISO 10993-1, -5, -10. Testing included Cytotoxicity, Skin Sensitization, Skin Irritation. (Results demonstrate biocompatibility) |
| Electrical Safety | Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) (Results show compliance) |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2: 2007 (Results show compliance) |
| Software Verification & Validation | Provided based on FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern. (Documentation and V&V were provided; no specific pass/fail metrics given in summary). |
| Cleaning Validation | Conducted per FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). Device shows no degradation after repeated cleaning/disinfection. (Validation conducted) |
| General Performance | Compliance with ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. (Bench testing conducted and results show compliance.) |
| Clinical Data | Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011. (No specific quantitative results from the clinical testing are summarized in this document beyond stating it was conducted per the guideline.) |
2. Sample size used for the test set and the data provenance:
- Test set sample size: The document states "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". This guideline typically specifies minimum numbers of subjects across a range of SpO2 values. However, the specific number of subjects or data points used in the clinical test is not provided in this 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the clinical data or whether it was retrospective or prospective. Clinical testing for pulse oximeters is typically prospective, involving human subjects purposefully desaturated under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For traditional pulse oximeters, the "ground truth" for SpO2 accuracy is typically established using a co-oximeter (a laboratory instrument that directly measures arterial oxygen saturation from blood samples) as the reference method, not by human experts adjudicating images. Therefore, the concept of "experts" to establish ground truth as would be relevant for an AI image analysis device does not apply in the context of this pulse oximeter's performance claims.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for a pulse oximeter. Adjudication methods are relevant for subjective interpretations, especially in image analysis, which is not how pulse oximeter accuracy is assessed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- An MRMC study is not applicable for a standalone device like a pulse oximeter. These studies are designed for AI devices that assist human readers in tasks like image interpretation. This device does not involve human readers for its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluation of the pulse oximeter is inherently a standalone (device-only) performance assessment. The device measures SpO2 and pulse rate, and its accuracy is directly compared against a reference standard (e.g., co-oximetry), without human intervention in the measurement or interpretation process.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- For pulse oximeters, the ground truth for oxygen saturation (SpO2) is typically established by arterial blood gas analysis with co-oximetry. This is the gold standard for measuring fractional oxyhemoglobin and other hemoglobin species, allowing for a precise determination of true arterial oxygen saturation. The document references "Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011," which outlines the methodology for such clinical studies.
8. The sample size for the training set:
- This device is a traditional medical device (pulse oximeter) that operates based on established physical principles (Lambert Beer Law, Photoelectric Oxyhemoglobin Inspection Technology) rather than a machine learning or AI algorithm that requires a "training set." Therefore, the concept of a "training set" does not apply to this device.
9. How the ground truth for the training set was established:
- Given that the device does not employ a machine learning algorithm with a "training set," this question is not applicable.
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December 22, 2021
Dongguan Lingxin Technologies Co., LTD % Reanny Wang Manager Shenzhen Reanny Medical Devices Mangement Consulting., Ltd Room 1813 of Gebu Commercial Building, Hongxing, Songgang Street, Baoan District Shenzhen, Guangdong 518000 China
Re: K210305
Trade/Device Name: Pulse Oximeter, Model: OX201 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: November 22, 2021 Received: November 22, 2021
Dear Reanny Wang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210305
Device Name Pulse Oximeter, Model: OX201
Indications for Use (Describe)
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(K) summary is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.
The assigned 510(k) number is: K210305
1.0 Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Dongguan Lingxin Technologies Co., LTD |
|---|---|
| Street Address: | Room 301, No.3 Liantang Road, Aoshitang, Dongcheng Street |
| City: | Dongguan |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(769)-89605029 |
| Fax: | +86(769)-89605029 |
| Contact Person: | Wayne |
| Contact Title: | General Manager |
| Contact Email: | Wayne@ijoyen.com |
Summary prepared: D December 22, 2021
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407#, Jingting Building, Dongzhou Community, Guangming Street,
Guangmeing District, Shenzhen 518000, China
Contact Person: Reanny Wang; E-mail: reanny@reanny.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Pulse Oximeter |
| Model: | OX201 |
| Classification name: | Oximeter |
| Review Panel: | Anesthesiology |
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| Product Code: | DQA |
|---|---|
| Device Class: | Class II |
| Regulation Number: | 870.2700 |
3.0 Predicate Device Information
| Sponsor: | Contec Medical Systems Co., Ltd. |
|---|---|
| Device: | CMS-50D Finger Pulse Oximeter |
| 510(K) Number: | K082641 |
4.0 Device Description
The OX201 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital.
The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, use it very easy.
Principle of the fingertip pulse oximeter as follows:
A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones.
Operation principle of the instrument:
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant dada is shown on the Oximeter's display through electronic circuits and a microprocessor.
5.0 Intended Use
The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.
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6.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Same |
| Appearance | Similar |
| Patients contact materials | Same |
| Performance | Similar |
| Biocompatibility | Same |
| Mechanical safety | Same |
| Energy source | Same |
| Electrical safety | Same |
| Standards met | Same |
| EMC | Same |
| Function | Similar |
7.0 Performance Summary
Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
Non-Clinical Testing:
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Pulse Oximeter was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests, results of which demonstrate the biocompatibility of the subject device:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
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Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the subject device complies with the IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2007 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
Bench Testing
Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Pulse Oximeter Equipment standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61. Clause 201.12.1.104.
Software Verification and Validation Testing
Software documentation including verification & validation was provided in accordance with FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for software with a moderate level of concern.
Cleaning Validation
Cleaning and disinfection validation testing was conducted in accordance with FDA quidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" issued March 17,2015. Moreover, the performance of the subject device shows no degradation after repeated cleaning and disinfection as suggested in the manual.
Clinical data:
Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO 2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
8.0 Comparison to predicate device
The subject device OX201 Pulse Oximeter is substantially equivalent to CMS-50D Fingertip Pulse Oximeter whose 510(k) number is K082641.
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| Elements ofComparison | Subject Device | Predicate Device(K082641) | Judgment |
|---|---|---|---|
| Company | Dongguan LingxinTechnologies Co., LTD | Contec Medical SystemsCo., Ltd. | -- |
| Device Name | Pulse Oximeter | Fingertip Pulse Oximeter | Same |
| Model | OX201 | CMS-50D | -- |
| 510(k) Number | Pending | K082641 | -- |
| Intended patientpopulation | Adult and Children | Adult and Children | Same |
| Intendedapplication site | Fingertip | Fingertip | Same |
| Intended use | The OX201 Pulse Oximeteris a non-invasive deviceintended for prescription usespot-checkof oxygen saturation ofarterial hemoglobin (SpO2)and pulse rate of adult andpediatricpatients (weight ≥ 40kg) inhome, hospital and clinicenvironments. The deviceis not intended forcontinuous monitoring, useduring motion or use withlow perfusion | The Fingertip PulseOximeter is a non-invasivedevice intended for spot-check of oxygen saturationof arterial hemoglobin(SpO2) and pulse rate ofadult and pediatric patientsin home and hospitalenvironments (includingclinical use in internist/surgery, anesthesia,intensive care, etc). Thedevice is not intended forcontinuous monitoring. | Same |
| Prescription orOTC | Prescription | Prescription | Same |
| Contact material | Silica rubber | Silica rubber | Same |
| Display type | Color OLED display, 4display directions | Color OLED display, 4display directions | Same |
| Measurementrange of SpO2 | 70-100% | 0-100% | Similar |
| Accuracy of SpO2 | 70%-100%, ±2%;Less than 70% nodefinition | 70%-100%, ±2%;Less than 70% nodefinition | Same |
| Elements ofComparison | Subject Device | Predicate Device(K082641) | Judgment |
| Resolution ofSPO2 | 1% | 1% | Same |
| Transducer ofSPO2 | Dual-wavelength LEDsensor | Dual-wavelength LEDsensor | Same |
| Measurementwavelength ofSPO2 | Red light:660nm, Infraredlight: 905nm | Red light: 660nm, Infraredlight: 880nm | SimilarNote 1 |
| Measurementrange of pulse rate | 25-250bpm | 20-250bpm | SimilarNote 2 |
| Accuracy of pulserate | ±2bpm or ±2% (whicheveris greater) | ±2bpm or ±2% (whicheveris greater) | Same |
| Resolution ofpulse rate | 1 bpm | 1 bpm | Same |
| Pulse intensity ofpulse rate | Bar graph indicator | Bar graph indicator | Same |
| Design principle | A mathematical formula is established making use ofLambert Beer Law according to Spectrum AbsorptionCharacteristics of Reductive hemoglobin (RHb) andOxyhemoglobin (HbO2) in glow and near-infrared zones.Operation principle of the instrument: PhotoelectricOxyhemoglobin Inspection Technology is adopted inaccordance with Capacity Pulse Scanning andRecording Technology, so that two beams of differentwavelength of light scan be focused onto a human nailtip through a clamping finger-type sensor. A measuredsignal obtained by a photosensitive element, will beshown on the Oximeter's display through process inelectronic circuits and microprocessor shown on theOximeter's display through electronic circuits and amicroprocessor. | Same | |
| Power source | DC3V, 2 × AAA batteries | DC3V, 2 × AAA batteries | Same |
| Other function | Low battery voltage indicate;Automatically power off;General setup and soundssetup and Bluetooth | Low battery voltage indicate;Automatically power off;General setup and soundssetup | SimilarNote 3 |
| Elements ofComparison | Subject Device | Predicate Device(K082641) | Judgment |
| Dimensions | 62 $\times$ 34 $\times$ 34mm(L $\times$ W $\times$ H) | 57 $\times$ 31 $\times$ 32mm(L $\times$ W $\times$ H) | Similar |
| Weight | 50g (including two AAAbatteries ) | 50g (including batteries) | Same |
| Operationcondition | 10-40°C, 15-95%RH,70kPa-106kPa | 5-40°C, ≤90%RH, 70kPa-106kPa | Similar |
| Storage condition | -20-60°C, 15-95%RH,70kPa-106kPa | -40-60°C, ≤95%RH,50kPa-106kPa | Similar |
| Classification | Internally poweredequipment, type BFapplied part | Internally poweredequipment, type BFapplied part | Same |
| Grade ofwaterproof | IPX2 | IPX1 | Similar |
| Material of appliedpart | Silicon rubber | Silicon rubber | Same |
| Material ofhousing | ABS | ABS | Same |
| Performance | Compliance with ISO80601-2-61 | Compliance with ISO 9919 | SimilarNote 4 |
| Biocompatibility | All the patient contactingmaterials are compliancewith ISO 10993-1/-5/-10 | All the patient contactingmaterials are compliancewith ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC60601-1 | Compliance with IEC60601-1 | Same |
| Safety of homehealthcareenvironment | Compliance with IEC60601-1-11 | -- | Similar |
| EMC | Compliance with IEC60601-1-2 | Compliance with IEC60601-1-2 | Same |
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As seen in the comparison tables, the subject and predicate devices have same design principle, similar design features and performance specifications. The different technological characteristics between the subject and predicate devices will not raise different questions of safety or effectiveness
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9. Conclusion
Verification and validation testing was conducted on the subject device Pulse Oximeter and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the subject device is substantially equivalent to the predicate device. The subject device and the predicate device has the same intended use, and technological differences does not raise different questions of safety and effectiveness.
§ 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).