(244 days)
Not Found
No
The device is a simple plastic probe cover for a thermometer and the summary contains no mention of AI or ML.
No
The device is a probe cover intended for use as a barrier for digital thermometers, not for treating or diagnosing a disease or condition. Its purpose is to prevent cross-contamination during temperature measurement.
No
The device is a probe cover for a thermometer, acting as a barrier and an accessory. It does not independently diagnose any medical condition.
No
The device description clearly states it is a "plastic covering" and the performance studies include biocompatibility and physical performance tests for a physical object (probe cover). There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a barrier for digital thermometers used for oral or axillary temperature measurement. This is a physical barrier to prevent contamination, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description confirms it's a plastic covering for a thermometer.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility and performance as a thermometer accessory (meeting standards for probe covers and electronic thermometers), not on the accuracy or performance of an in vitro diagnostic test.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body to diagnose diseases or conditions. This probe cover is a physical accessory used with a thermometer for in-vivo (within the body) temperature measurement.
N/A
Intended Use / Indications for Use
The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Probe Cover is a plastic covering used for oral/axillary digital thermometer. This device is not made with natural rubber latex. Refer to user manual for the recommend thermometers that probe covers can be used with.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral or axillary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility Tests: The Probe Cover has been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include: ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity. ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin sensitization.
Performance Tests: ASTM E1104-98 (Reapproved 2016): Standard Specification for Clinical Thermometer Probe Covers and Sheaths. ASTM E1112-00 (Reapproved 2011): Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. Conclusion: The Probe Cover have demonstrated the product has similar intended use and similar technological characteristics as that of the predicate device. Performance testing showed it performs in a manner that is substantially equivalent to the legally marketed predicate device.
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.
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
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 22, 2021
Shenzhen Juzhong Technology Co., Ltd % Long Yang CEO Shenzhen Hlongmed Biotech Co., Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan Shenzhen, Guangdong 518000 China
Re: K202009
Trade/Device Name: Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 30, 2021 Received: February 19, 2021
Dear Long Yang:
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 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.
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K202202
Device Name
Probe Cover
Model:1Z-KBT-001, IZ-KBT-002, IZ-KBT-007, JZ-KBT-007, JZ-KBT-009, IZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026
Indications for Use (Describe)
The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K202009 510(k) Summary
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.
Date of Summary: March 12, 2021
1. Submitter
ShenZhen JuZhong Technology Co.,Ltd. Block B, floor 3, building 38, Sanhe Village, Gaofeng community, Dalang street, Longhua District, Shenzhen
2. Contact Person
2.1 Primary Contact Person
Long Yang (COO) Shenzhen Hlongmed Biotech Co.,Ltd. 1201, Haosheng Business Center, 4096 Dongbin Road, Nanshan, Shenzhen, P.R.C Tel: 0086-755-86664986 Fax: 0086-755-86664933 E-mail: yanglong@hlongmed.com
2.2 Secondary Contact Person
Chang LiHua(Manager) ShenZhen JuZhong Technology Co.,Ltd. Block B, floor 3, building 38, Sanhe Village, Gaofeng community, Dalang street, Longhua District, Shenzhen Tel: +86 0755-27764799 Fax: +86 0755-27764022 E-mail: jack clh@163.com
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3. Proposed Device Information
Trade name: Probe Cover
Model:JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 Common name: Disposable Thermometer Sheaths Classification name: Clinical electronic thermometer Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 21 CFR 880.2910
4. Predicate Device Information
510(k) Number: K102508
Manufacturer: YU LONG SHENG TECHNOLOGY CO.,LTD Trade Name: Yu Long Sheng Disposable Thermometer Sheath, Model YSL-01 Classification name: Clinical electronic thermometer Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 21 CFR 880.2910
5. Device Description
The Probe Cover is a plastic covering used for oral/axillary digital thermometer. This device is not made with natural rubber latex. Refer to user manual for the recommend thermometers that probe covers can be used with.
6. Intended use
The Probe Cover is intended for use as a barrier that is used as an accessory to oral or axillary for digital thermometers. This Probe Cover is non-sterile and is intended for single patient use only.
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7. Comparison to Predicate Device
The Probe Cover have the similar intended use, similar technological characteristics as the following predicate device and are substantially equivalent with regards to safety and effectiveness.
K102508 Yu Long Sheng Disposable Thermometer Sheath, manufactured by YU LONG SHENG TECHNOLOGY CO.,LTD
The following table shows similarities and differences of technological characteristics between our device and the predicate devices.
| Item | Subject Device
(K202009) | Predicate Devices
(K102508) | Remark |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name | Probe Cover | Yu Long Sheng Disposable /
Thermometer Sheath | |
| Model | JZ-KBT-001, JZ-KBT-002,
JZ-KBT-005,JZ-KBT-007,
JZ-KBT-008, JZ-KBT-009,
JZ-KBT-010, JZ-KBT-015,
JZ-KBT-025, JZ-KBT-026 | YLS-01 | / |
| Classifications
Name &
Citations | 21 CFR 880.2910 Clinical
electronic thermometer (FLL) | 21 CFR 880.2910 Clinical
electronic thermometer (FLL) | Same |
| Intended Use | Probe Cover is intended for use
as a barrier that is used as an
accessory to oral or axillary for
digital thermometers. This
probe cover is non-sterile and
is intended for single patient
use only. | YLS-01 disposable thermometer
sheath is intended for use as a
barrier that is used as an
accessory to oral or rectal for
digital thermometers. This
thermometer sheath is non-
sterile and is intended for single
patient use only. | Different 1 |
| Construction | PE film with upper and lower
exterior protection paper. | EVA film with upper and lower
exterior protection paper. | Different 2 |
| Natural rubber
latex | Do not contain natural rubber
latex | Do not contain natural rubber
latex | Same |
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ShenZhen JuZhong Technology Co.,Ltd.
| Use type | For single use | For single use | Same |
|---|---|---|---|
| Size of single | |||
| piece | 125×30mm; | ||
| 150×40mm; | |||
| 125×40mm; | |||
| 150×70mm; | |||
| 235×50mm; | |||
| 235×70mm; | |||
| 235×35mm; | |||
| 100×30mm; | 94×26mm | Different 3 | |
| Package unit | 100pcs in one packaging unit; | ||
| 50pcs in one packaging unit; | 50 pcs in one packaging unit | Different 4 | |
| Sterile Package | Non-sterile package | Non-sterile package | Same |
| Biocompatibility | |||
| test | Biocompatibility test according to ISO 10993-5&ISO 10993-10 | Biocompatibility test according to ISO 10993-5&ISO 10993-10 | Same |
| Performance test | Performance test according to ASTM E 1104-98 &ASTM E 1112-00 | Performance test according to ASTM E 1104-98 &ASTM E 1112-00 | Same |
Our device and the predicate device differ in the following areas.
(1) Intended use
The intended use of proposed device is to used as an an accessory to oral or axillary for digital thermometers. While the intended use of predicate device is used as an accessory to oral or rectal for digital thermometers. The different is just the body contact site. Biocompatibility test is conducted on the proposed device and the result is qualified. The biocompatibility is safe. At the same time the performance test of proposed device is conducted according to ASTM E 1104-98 &ASTM E 1112-00 and the result is qualified. The product is safe and effective.
So this difference does not affect the effectiveness and safety of our device.
(2) Construction
The construction of proposed device is PE film with upper and Lower exterior protection
7
paper. While the construction of predicate device is EVA film with upper and Lower exterior protection paper. The different is just the material of film. Biocompatibility test is conducted on the proposed device and the result is qualified. The biocompatibility is safe. At the same time the performance test of proposed device is conducted according to ASTM E 1104-98 &ASTM E 1112-00 and the result is qualified. The product is safe and effective.
So this difference does not affect the effectiveness and safety of our device.
(3) Size of single piece
The size of single piece of proposed device is varied size. While the size of single piece of predicate device is 94×26mm. Every size of propose device is conducted according to ASTM E 1104-98 &ASTM E 1112-00 and the result is qualified. All sizes of proposed device are safe and effective.
So this difference does not affect the effectiveness and safety of our device.
(4) Package unit
The package unit of proposed device is varied. Different model with varied pieces in packaging unit. While the predicate device is only one model and 50 pieces in one package unit. The package does not affect the clinical use of the device.
So this difference does not affect the effectiveness and safety of our device.
8. Non-Clinical Performance Data
Biocompatibility Tests
The Probe Cover has been evaluated in accordance with Part 10993 of the International Standard Organization (ISO). Standard tests administered include:
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin sensitization.
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Performance Tests
- ASTM E1104-98 (Reapproved 2016): Standard Specification for Clinical Thermometer Probe Covers and Sheaths
- ASTM E1112-00 (Reapproved 2011): Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Conclusion: The Probe Cover have demonstrated the product has similar intended use and similar technological characteristics as that of the predicate device. Performance testing showed it performs in a manner that is substantially equivalent to the legally marketed predicate device.
9. Substantial Equivalent Conclusions
Probe Cover has the similar intended use, similar technological characteristics as the predicate device. Moreover, non-clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness.
In conclusion, Probe Cover is substantial equivalent to the predicate device.