(179 days)
No
The device description and performance studies focus on standard pulse oximetry technology and do not mention any AI or ML components or capabilities.
No
Explanation: The device is intended for spot checking of functional oxygen saturation and pulse rate, which are diagnostic measurements, not therapeutic interventions. The "Intended Use" section clearly states it is a "non-invasive device intended for spot checking."
Yes
The device is intended for "spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)," which are measurements used to assess a patient's physiological state and can inform a diagnosis.
No
The device description explicitly lists hardware components such as a PCB board, On/Off button, screen, battery compartment, and plastic shell, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Fingertip Pulse Oximeter Function: The description clearly states that the Fingertip Pulse Oximeter is a non-invasive device that measures oxygen saturation and pulse rate by applying a sensor to the finger. It works by analyzing light absorption through the skin and tissue, not by testing a sample taken from the body.
The device is a non-invasive medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
Product codes
DQA
Device Description
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by 2 AAA alkaline batteries.
The device mainly composed of PCB board, On/Off button, OLED or LED or LED screen, battery compartment, and plastic shell.
The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for lifesupporting or life-sustaining.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Finger
Indicated Patient Age Range
Adults
Intended User / Care Setting
Clinical institution and home environments.
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)
Clinical studies were conducted to verify the accuracy of proposed device. The clinical studies were conducted per following standards:
- ISO 80601-2-61: 2017 Medical Electrical Equipment - Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment.
- Pulse Oximeters-Premarket Notification Submissions: Guidance for Industry and Food and Drug Administration Staff
Clinical testing has been performed under an approved protocol with subject informed consent. Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Pulse Oximeter versus arterial oxygen saturation (SaO2) as determined by co-oximetry. Clinical test results support device accuracy claims for the specified saturation range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 Accuracy: 70% ~ 100%, Arms ± 3%.
§ 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).
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July 30, 2021
Zhuhai Linte Medical Instrument Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong 518067 China
Re: K210274
Trade/Device Name: Fingertip Pulse Oximeter, Model LT-F20 and LT-F21 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: June 29, 2021 Received: July 2, 2021
Dear Kevin 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.
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
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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 (QS) 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/cdrh-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 ENT, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210274
Device Name
Fingertip Pulse Oximeter, model: LT-F20 and LT-F21
Indications for Use (Describe)
The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2021/07/25
1. Submission sponsor
Name: Zhuhai Linte Medical Instrument Co., Ltd.
Address: 4th Floor, Building 1, No.66, Yongda Road, Hongqi Town, Jinwan District, Zhuhai, Guangdong 519090 P.R. China
Contact person: Kezheng Ma
Title: Management Representative
E-mail: mark.ma(@)lintemed.com
Tel: +86 135 30230360
2. Submission correspondent
Name: Chonconn Medical Device Consulting Co., Ltd.
Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067
Contact person: Kevin Wang
E-mail: kevin(@chonconn.com
Tel: +86-755 33941160
| 3. Subject Device Information | |
|---|---|
| Trade/Device Name | Fingertip Pulse Oximeter |
| Model | LT-F20 and LT-F21 |
| Common Name | Fingertip Pulse Oximeter |
| Regulatory Class | Class II |
| Classification | 21CFR 870.2700 / Oximeter / DQA |
| Submission type | Traditional 510(K) |
3. Subject Device Information
4. Predicate Device
Manufacturer: Shenzhen Aeon Technology Co., Ltd. Device name: Pulse Oximeter 510(K) Number: K190869
ട്. Device Description
The Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).
The Fingertip Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a
4
constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by 2 AAA alkaline batteries.
The device mainly composed of PCB board, On/Off button, OLED or LED or LED screen, battery compartment, and plastic shell.
The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for lifesupporting or life-sustaining.
6. Intended use & Indication for use
The Fingertip Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
| 7. Comparison to the Predicate Device | |||
|---|---|---|---|
| Features | Subject Device | Predicate Device K190869 | |
| AEON Pulse Oximeter | Comparison | ||
| Fingertip Pulse Oximeter | n | ||
| Applicant | Zhuhai Linte Medical | ||
| Instrument Co., Ltd. | Shenzhen Aeon Technology | ||
| Co., Ltd. | / | ||
| Classification | |||
| Regulation | 21CRF 870.2700 | 21CRF 870.2700 | Same |
| Classification and | |||
| Code | Class II, DQA | Class II, DQA | Same |
| Common name | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | Same |
| Intended use | The Fingertip Pulse Oximeter | ||
| is a non-invasive device | |||
| intended for spot checking of | |||
| functional oxygen saturation of | |||
| arterial hemoglobin (SpO2) | |||
| and pulse rate (PR). This | |||
| portable device is indicated for | |||
| use in adult patients in clinical | |||
| institution and home | |||
| environments. | The Pulse Oximeter is a non- | ||
| invasive device intended for | |||
| spot checking of functional | |||
| oxygen saturation of arterial | |||
| hemoglobin (SpO2) and pulse | |||
| rate (PR). This portable device | |||
| is indicated for use in adult | |||
| patients in clinical institution | |||
| and home environments. | Same | ||
| Patient populations | Adults | Adults | Same |
| Principle | The device displays numerical | ||
| values for functional oxygen | |||
| saturation of arterial | |||
| hemoglobin (SpO2) and pulse | The device displays numerical | ||
| values for functional oxygen | |||
| saturation of arterial | |||
| hemoglobin (SpO2) and pulse | Same | ||
| Features | Subject Device | ||
| Fingertip Pulse Oximeter | Predicate Device K190869 | ||
| AEON Pulse Oximeter | Comparison | ||
| rate by measuring the | |||
| absorption of red and infrared | |||
| (IR) light passing through | |||
| perfused tissue. Changes in the | |||
| absorption caused by the | |||
| pulsation of blood in the | |||
| vascular bed are used to | |||
| determine oxygen saturation | |||
| and pulse rate. | rate by measuring the | ||
| absorption of red and infrared | |||
| (IR) light passing through | |||
| perfused tissue. Changes in the | |||
| absorption caused by the | |||
| pulsation of blood in the | |||
| vascular bed are used to | |||
| determine oxygen saturation | |||
| and pulse rate. | |||
| Light Emitting | Red: 660 nm | ||
| Infrared: 905 nm | Red: 660 nm | ||
| Infrared: 905nm | Same | ||
| Power source | 2 AAA alkaline batteries | 2 AAA alkaline batteries | Same |
| Display data | SpO2%, PR | SpO2%, PR | Same |
| SpO2 Measuring | |||
| Range | 35%-100% | 35%-100% | Same |
| SpO2 Resolution | 1% | 1% | Same |
| SpO2 Accuracy | 70% ~ 100%, Arms ± 3%. |