(113 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is for a standard pulse oximeter.
No
The device is described as a non-invasive device for spot-checking functional oxygen saturation and pulse rate. It explicitly states, "The device is not for life supporting or life sustaining." This indicates it's a diagnostic or monitoring device, not one intended for treating or alleviating a disease or condition.
Yes
Explanation: The device measures functional oxygen saturation (SpO2) and pulse rate (PR) to identify indicators of a medical condition.
No
The device description explicitly states it is a "portable fingertip device" and a "stand-alone device, which is powered by an internal battery," 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 that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Pulse Oximeter is a "non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)." It measures these parameters through a patient's finger, without taking any samples from the body.
- Lack of Specimen Analysis: The device does not analyze any biological specimens. It uses light absorption through the fingertip to determine SpO2 and pulse rate.
Therefore, based on the provided information, the Pulse Oximeter described is a non-invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Pulse Oximeter is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.
The Pulse Oximeter is as a stand-alone device, which is powered by an internal battery. The device is for multi-use. The device is not for life supporting or life sustaining, not for implant. The device is not sterile, the device is not a reprocessed single-use device, and the device does not contain drug or biological products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
Home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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
The functional oxygen saturation (SpO2) measurement has been validated in accordance with ISO 80601-2-61. The clinical testing was completed on healthy, non-smoking, a total of 12 healthy adult volunteers (5 men and 7 women) with light to dark skin pigmentations in the range of 70% to 100% against a laboratory CO-Oximeter. The subjects include 10 with light skin, and 2 with dark skin pigmentation. Total 278 data points were sampled for analysis. The measured arterial hemoglobin saturation value (SpO2) of the proposed device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. The accuracy of the device is in comparison with the CO-oximeter samples measured over the SpO2 range 70%-100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was performed to validate functional oxygen saturation (SpO2) measurement in accordance with ISO 80601-2-61. The study involved 12 healthy adult volunteers (5 men, 7 women) with varied skin pigmentations. A total of 278 data points were analyzed.
Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-2-61, the SpO2 accuracy result showed that the root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100%; and the Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, the analysis demonstrated that the vast majority of data is within ±95% limit of agreement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 accuracy: root-mean-square (Arms) value is less than ±2% SpO2 over the declared range of 70% to 100%.
Agreement between Methods of Measurement: vast majority of data within ±95% limit of agreement based on Bland and Altman statistics.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2021
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. John Liu RA Manager Floor 14, Block D, Dianlian Technology Building, the Crossing between South Circle Road and South Fuli Road, Shenzhen, Guangdong 518106 China
Re: K203854
Trade/Device Name: Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: March 23, 2021 Received: March 23, 2021
Dear John Liu:
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
1
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
2
Indications for Use
510(k) Number (if known) K203854
Device Name Pulse Oximeter
Indications for Use (Describe)
The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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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Image /page/3/Picture/2 description: The image contains a logo for ZONDAN. The logo features a green graphic of two overlapping cards with a white heart and heartbeat symbol on them. To the right of the graphic is the company name "ZONDAN" in bold, black letters, and below that is the tagline "Core Technology Care for Life" in a smaller, gray font.
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of 21 CFR 807.92.
1. Submitter's Identification
| Applicant: | Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. |
|---|---|
| Address: | Floor 14, Block D, Dianlian Technology Building, the |
| Crossing between South Circle Road and South Fuli Road, | |
| Guangming District, 518106 Shenzhen, Guangdong, China | |
| Contact person: | Li Feng |
| General Manager | |
| Tel: +86-755-26865970 | |
| E-mail: 13602607257@163.com | |
| Prepared by: | Mr. John Liu |
| Regulatory Manager | |
| E-mail: liuming@zondan.com | |
| Date prepared: | Dec. 21, 2020 |
2. Subject device information
Device Common Name: Oximeter Device Trade Name: Pulse Oximeter Model: A2, A3, A4, A5 Regulation Number: 21 CFR 870.2700 Regulation Name: Oxiemter Regulatory Class: II Product Code: DQA
3. Predicate device information
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Image /page/4/Picture/2 description: The image shows the logo for Zondan. The logo consists of a green square with a white heart and an EKG line inside of it. To the right of the square is the word "ZONDAN" in large, bold, black letters. Below the word "ZONDAN" is the phrase "Core Technology Care for Life" in smaller, gray letters.
510(k) Number: K163135 Trade/ Device Name: Fingertip Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Manufacturer: Shenzhen Fitfaith Technology Co., Ltd.
4. Device description
The Pulse Oximeter is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.
The Pulse Oximeter is as a stand-alone device, which is powered by an internal battery. The device is for multi-use. The device is not for life supporting or life sustaining, not for implant. The device is not sterile, the device is not a reprocessed single-use device, and the device does not contain drug or biological products.
5. Intended Use
The Pulse Oximeter is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.
6. Indication for Use
The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
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Image /page/5/Picture/2 description: The image shows the logo for ZONDAN. The logo consists of a green graphic on the left, which includes a white heart with an EKG line inside of it. To the right of the graphic is the company name, "ZONDAN" in bold, black letters. Below the company name is the tagline "Core Technology Care for Life" in a smaller, gray font.
7. Substantial Equivalence Comparison
| Characteristics | Subject device | Predicate device
(K163135) | Remark |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name | Pulse Oximeter | Fingertip Pulse
Oximeter | NA |
| Model | A2, A3, A4, A5 | A300 | NA |
| Manufacturer | Shenzhen Hexin
ZONDAN Medical
Equipment Co.,Ltd. | Shenzhen Fitfaith
Technology Co., Ltd. | NA |
| Classification | Class II | Class II | Substantially
Equivalent. |
| Product code | DQA | DQA | Substantially
Equivalent. |
| Prescription or
OTC | Prescription | Prescription | Substantially
Equivalent. |
| Intended use | The Pulse Oximeter is
intended for measuring
the functional oxygen
saturation and pulse
rate (PR) through a
patient's finger. It is
applicable for
spot-checking SpO2
and pulse rate (PR) of
adult and pediatric
patients in homes and
clinics. | The Fingertip Pulse
Oximeter is intended
for measuring the
functional oxygen
saturation and pulse
rate (PR) through a
patient's finger. It is
applicable for
spot-checking SpO2
and pulse rate (PR) of
adult and pediatric
patients in homes and
clinics. | Substantially
Equivalent. |
| Indications for | The Pulse Oximeter is | The Fingertip Pulse | Substantially |
| use | non-invasive device
intended for
spot-checking of
functional oxygen
saturation of arterial
hemoglobin (SpO2) and
pulse rate (PR). The
portable fingertip
device is indicated for
adult and pediatric
patients in home and
hospital environments
(including clinical use
in internist/ surgery,
anesthesia, intensive
care, etc). | Oximeter is
non-invasive device
intended for
spot-checking of
functional oxygen
saturation of arterial
hemoglobin (SpO2)
and pulse rate (PR).
The portable fingertip
device is indicated for
adult and pediatric
patients in home and
hospital environments
(including clinical use
in internist/ surgery,
anesthesia, intensive
care, etc). | Equivalent. |
| Design principle | A mathematical formula is established making
use of Lambert Beer Law according to Spectrum
Absorption Characteristics of Reductive
hemoglobin (RHb) and Oxyhemoglobin (HbO2)
in red 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 can be
focused onto a human nail tip through a
clamping finger-type sensor A measured signal | | Substantially
Equivalent. |
| Environment of
use | Home and Hospital | Home and Hospital | Substantially
Equivalent. |
| Patient type | Adult and Pediatric | Adult and Pediatric | Substantially
Equivalent. |
| Intended
application site | Fingertip | Fingertip | Substantially
Equivalent. |
| Type, Degree of
protection
against electric
shock | Internally powered
equipment;
Type BF applied part. | Internally powered
equipment;
Type BF applied part. | Substantially
Equivalent. |
| Power supply | 2AAA 1.5V alkaline
battery | 2AAA 1.5V alkaline
battery | Substantially
Equivalent. |
| Work current |