Who is the manufacturer of Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

Shenzhen Zhengkang Technology Co., Ltd. filed the 510(k) submission for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) (K213984).

What is the FDA product code for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

DQA. It is classified under 21 CFR 870.2700 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

Fingertip Pulse Oximeter (K163135).

Who can help prepare an FDA 510(k) submission like Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)

K213984 · Shenzhen Zhengkang Technology Co., Ltd. · DQA · Dec 16, 2022 · Cardiovascular

Device Facts

Record ID	K213984
Device Name	Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
Applicant	Shenzhen Zhengkang Technology Co., Ltd.
Product Code	DQA · Cardiovascular
Decision Date	Dec 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2700
Device Class	Class 2

Intended Use

The 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 patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

Device Story

Portable fingertip pulse oximeter; measures functional SpO2 and pulse rate via non-invasive photoelectric technology. Device uses two light wavelengths (660nm red, 905nm infrared) focused on nail tip; sensor detects light absorption changes based on Lambert-Beer Law and Capacity Pulse Scanning. Microprocessor processes signals to calculate SpO2 and PR; results shown on integrated display. Used by clinicians or patients for spot-checking in home/hospital environments. Provides immediate physiological data to assist in clinical assessment; benefits include rapid, non-invasive monitoring of oxygenation status.

Clinical Evidence

Clinical hypoxia accuracy testing conducted on 12 healthy, non-smoking adults (18-50 years) under induced hypoxia in non-motion/static conditions. 300 data sets collected (289 valid). Accuracy compared against CO-oximeter control device over 70-100% SpO2 range. Analysis used mean bias (B), root-mean-square (Arms), and Bland-Altman statistics. Results met ISO 80601-2-61 criteria; no adverse effects reported.

Technological Characteristics

Fingertip pulse oximeter; ABS enclosure, silica gel clip. Dual-wavelength sensing (660nm red, 905nm infrared). Powered by 2x AAA batteries (3V). Connectivity: standalone. Standards: ISO 80601-2-61, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Biocompatibility per ISO 10993-5, -10, -23.

Indications for Use

Indicated for adult patients in home and hospital settings for non-invasive spot-checking of functional arterial hemoglobin oxygen saturation (SpO2) and pulse rate (PR). Contraindicated for patients in cardiac arrest or shock, or those with severe hypotension, severe vasoconstriction, severe anemia, or hypothermia. Not for use with high-frequency electrosurgical equipment, or on extremities with blood pressure cuffs, arterial catheters, or intravascular lines. Fingernail polish or false nails may cause inaccuracies.

Regulatory Classification

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.

Predicate Devices

Fingertip Pulse Oximeter (K163135)

Reference Devices

Fingertip Pulse Oximeter (K161938)

Related Devices

K093757 — MD300C1 FINGERTIP PULSE OXIMETER · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 3, 2010
K140582 — FINGERTIP PULSE OXIMETER · Shenzhen Jumper Medical Equipment Co., Ltd. · Aug 28, 2014
K190869 — Pulse Oximeter · Shenzhen Aeon Technology Co., Ltd. · Sep 13, 2019
K172616 — Pulse Oximeter · Beijing Safe Heart Technology , Ltd. · Jul 27, 2018
K230172 — Pulse Oximeter · Beijing Choice Electronic Technology Co., Ltd. · Aug 12, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 16, 2022 ShenZhen ZhengKang Technology Co., Ltd. % Becky Chen Registered Engineer Feiving Drug & Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu Guangzhou, Guangdong 510000 China Re: K213984 Trade/Device Name: Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: December 9, 2022 Received: December 12, 2022 Dear Becky Chen: 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. {1}------------------------------------------------ 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 (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 medical devices and radiation-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. James J. Lee -S James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia 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) K213984 Device Name Oximeter (Model: JZK-301, JZK-303, JZK-305, JZK-307) Indications for Use (Describe) The 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 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510 (k) Summary This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92. #### (1) Applicant information: | 510(k) owner's name: | ShenZhen ZhengKang Technology Co., Ltd. | |----------------------------|------------------------------------------------------------------------------------------------------------------------------| | Address: | 2&3/F, Building A, No. 3 FuXing Yi Lane, HeHua Community, PingHu Street, LongGang District, ShenZhen, GuangDong, China | | Contact person: | Huayong Yang | | Phone number: | +86-755-83260864 | | Fax number: | +86-755-83251427 | | Email: | 893488645@qq.com | | Date of summary prepared: | 12/14/2022 | | Reason for the submission: | New device, there were no prior submissions for the device. | # (2) Proprietary name of the device | Trade name/model: | Oximeter / JZK-301, JZK-303, JZK-305, JZK-307 | |--------------------|-----------------------------------------------| | Common name: | Oximeter | | Regulation number: | 21CFR 870.2700 | | Product code: | DQA | | Review panel: | Anesthesiology | | Regulation class: | Class II | ## (3) Predicate device and Reference Device | | Predicate Device | Reference Device | |----------------------|------------------------------------------|------------------------------------------------------------| | Sponsor | Shenzhen Fitfaith Technology Co.,Ltd. | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | | Device Name/Model | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | | 510(k) Number | K163135 | K161938 | | Product Code | DQA | DQA | | Regulation Number | 21CFR 870.2700 | 21CFR 870.2700 | | Regulation Class | II | II | {4}------------------------------------------------ #### (4) Description/ Design of device: The Oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult patients in the home and hospital. The oximeter features a small size, low power consumption, a convenient operation, and portability. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement. Principle of the 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 red and infrared zones. 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 red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor. The four models (JZK-301, JZK-303, JZK-305, and JZK-307) have the same intended use, working principle, characteristic, and conformance standards, only in appearance have some different (appearance design, dimension, and weight). #### (5) Intended use The subject device 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 patients in homes and clinics. #### (6) Indications for Use: The 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 patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc). #### (7) Contraindications - High-frequency electrosurgical A - A Placement of a sensor on an extremity with a blood pressure cuff arterial catheter, or intravascular line - A The patient has hypotension severe vasoconstriction severe anemia or hypothermia. - A The patient is in cardiac arrest or is in shock. - A Fingernail polish or false fingernails may cause inaccurate SpO2 readings. #### (8) Materials {5}------------------------------------------------ | Test Article Name | Body Contact Category | Contact Duration | |-------------------|-----------------------|-------------------------| | Oximeter | Surface skin contact | Prolonged (>24h to 30d) | We have tested the oximeters and obtained the Biocompatibility test reports. For details, please refer to "Biocompatibility Discussion". | Characteristics | Targeted device | Predicate device | Reference device | Remark | | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name | Oximeter | Fingertip Pulse Oximeter | Fingertip Pulse Oximeter | / | | | Model | JZK-301, JZK-303, JZK-305, JZK-307 Note: The 4 models have the same technological characteristics, only in appearance have some different. | A300, A310, M100, M110, M120, M130, M150, M160, M170, M230 Note: A300 and M110 are totally identical model except for model name based on Customer's requirement; A310 and M100 are totally identical model except for model name based on Customer's requirement | YK-81C | / | | | Manufacturer | ShenZhen ZhengKang Technology Co., Ltd. | Shenzhen Fitfaith Technology Co.,Ltd. | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | / | | | 510 (k) number | Pending | K163135 | K161938 | / | | | Regulation number | 21CFR 870.2700 | 21CFR 870.2700 | 21CFR 870.2700 | Same | | | Regulation description | Oximeter | Oximeter | Oximeter | Same | | | Product code | DQA | DQA | DQA | Same | | | Class | II | II | II | Same | | | Intended use | The subject device is intended for | The subject device is intended for | The pulse oximeter, | Same. Within | | | Characteristics | Targeted device | Predicate device | Reference device | Remark | | | | 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 patients in homes and clinics. | 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. | YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | the range of predicate device. (The predicate device is intended for use by adult and pediatric patient, our device is intended for use by adult patient only. | | | | Indications for use | The 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 patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc). | The Fingertip 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). | The pulse oximeter (YK-81C) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. | Same. Within the range of predicate device. (The predicate device is intended for use by adult and pediatric patient, our device is intended for use by adult patient only. | | | Intended patient population | Adult | Adult & Pediatric | Adult | Same with | | Characteristics | Targeted device | Predicate device | Reference device | Remark | | | | | | | reference device; Within the range of predicate device. | | | Intended application site | Fingertip | Fingertip | Fingertip | Same | | | Intended environments | Home & hospital | Home & hospital | Clinic | Same with predicate device | | | Prescription & OTC | Prescription | Prescription | Prescription | Same | | | Working 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 | 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 | / | Same | | | Characteristics | Targeted device | Predicate device | Reference device | Remark | | | | of lights can be focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the Oximeter's display through process in electronic circuits and microprocessor. | focused onto a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the Oximeter's display through process in electronic circuits and microprocessor. | | | | | Wavelength | Red light: 660nm $\pm$ 3nm Infrared light: 905nm $\pm$ 5nm | Red light: 660nm $\pm$ 3nm Infrared light: 905nm $\pm$ 5nm | Red light: 660nm Infrared light: 940nm | Same with predicate device | | | Maximum optical power | 21.8 mW for red light (660nm) 5 mW for IR (905nm) | 1.5 mW for red light (660nm) 1.2 mW for IR (905nm) | 21.8 mW | Similar Note 1 | | | Contact material | ABS for enclosure silica gel for clip | ABS for enclosure silica gel for clip | / | Same | | | Internal Power supply | DC 3V (two AAA alkaline batteries) | 2*AAA 1.5v alkaline battery | 2 AAA alkaline batteries | Same | | | Working current | Less than 40mA(Normal) | Less than 40mA(Normal) | / | Same | | | Resolution | SpO2: 1% Pulse rate: 1 bpm | SpO2: 1% Pulse rate: 1 bpm | SpO2: 1% Pulse rate: 1 bpm | Same | | | Measurement range | SpO2: 45-100% Pulse rate: 25-250 bpm | SpO2: 0-100% Pulse rate: 25-250 bpm | SpO2: 0-100% Pulse rate: 30-254 bpm | Similar Note 2 | | | Measurement accuracy | SpO2: $\pm$ 2%: (70%~100%) Unspecified for <70% | SpO2: $\pm$ 2%:(70%~100%) Unspecified: (0%~69%) | SpO2: $\pm$ 3%: (70%~100%) Unspecified: (0%~69%) | Same with predicate device | | | | Pulse rate: $\pm$ 2 bpm | Pulse rate: $\pm$ 2 bpm | Pulse rate: $\pm$ 2 bpm | | | | Operating environment | Temperature: 5℃~40℃ | Temperature: 5℃~40℃ | / | Similar Note 3 | | | Characteristics | Targeted device | Predicate device | Reference device | Remark | | | | Humidity: ≤80%RH | Humidity: 15~85%RH (non-condensing)…