Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Allerhope® Allergy Skin Tester. It aims to demonstrate substantial equivalence to a predicate device, the Multi-Test II by Lincoln Diagnostics, Inc. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets these criteria.

Specifically, the document focuses on non-clinical testing for biocompatibility, sterility, and some performance aspects (flexural properties, Izod impact strength). It explicitly states that a "comparison test over allergenic extracts delivery function has been conducted," but it does not provide the acceptance criteria for this test, the detailed results, or the methodology (e.g., sample size, ground truth establishment, expert involvement, MRMC study details).

Therefore, I can only provide information based on what is available in the document.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available in the document:

Device: Allerhope® Allergy Skin Tester

Study Objective (as implied by 510(k)): To demonstrate substantial equivalence of the Allerhope® Allergy Skin Tester to the predicate device (Multi-Test II by Lincoln Diagnostics, Inc.) for the percutaneous administration of diagnostic allergenic extracts.

1. Table of acceptance criteria and reported device performance:

Characteristic	Acceptance Criteria (Stated/Implied)	Reported Device Performance (Summary)
Intended Use	Same as predicate: Percutaneous administration of diagnostic allergenic extracts.	Same as predicate.
Product Code	LDH (as per predicate)	LDH
Product Structure	Multiple heads and points (same as predicate)	Multiple heads and points (PROSPT, PROSPT II models).
Material (Body)	Acrylic plastic (PMMA) (same as predicate)	Acrylic plastic (PMMA)
Color Additive	Titanium dioxide (same as predicate)	Titanium dioxide
Biocompatibility	Meet ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2006, USP_NF32<85> standards.	Tests conducted: In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity, Endotoxin Test. (Results not detailed, but implied as meeting criteria for substantial equivalence).
Sterility	SAL=10^-6 (implied) and meet ISO11737-2:2009.	Gamma sterilization conducted; Sterility Test performed. (Results not detailed, but implied as meeting criteria for substantial equivalence).
Performance (Flexural Properties)	Meet ISO178:2010 standards.	Flexural Properties Test conducted. (Results not detailed, but implied as meeting criteria for substantial equivalence).
Performance (Izod Impact Strength)	Meet ISO180:2000 standards.	Izod Impact Strength Test conducted. (Results not detailed, but implied as meeting criteria for substantial equivalence).
Allergenic Extract Delivery Function	"Subject device can carry extracts as predicate device." (Specific quantitative criteria and threshold are not provided in this document.)	"A comparison test over allergenic extracts delivery function has been conducted between subject device and predicate device. The result shows that the subject device can carry extracts as predicate device." (Specific quantitative results are not provided).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for any of the performance tests, including the "allergenic extracts delivery function" comparison.
Data Provenance: The tests were conducted to support a submission from a company in China (Zhengzhou, Henan, China). It is implied these were prospective tests performed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Provided. The document describes non-clinical engineering and laboratory tests, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth in the typical sense of an AI/human reader study. For the "allergenic extracts delivery function" test, the document does not specify who conducted the comparison or how the "can carry extracts" conclusion was reached in terms of expert involvement.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable / Not Provided. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads). The tests described are laboratory performance tests.

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:

No. This document describes a 510(k) submission for a physical medical device (allergy skin tester), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed and is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. Again, this is not an AI algorithm. The performance tests would be akin to "standalone" performance of the device in a laboratory setting, but not in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the biocompatibility and sterility tests, the "ground truth" is adherence to established international standards (ISO, USP).
For the physical performance tests (Flexural Properties, Izod Impact Strength), the "ground truth" is adherence to specific ISO standards.
For the "allergenic extracts delivery function" comparison, the ground truth is simply whether the subject device performs as well as the predicate device in carrying extracts. The methodology for determining this "truth" (e.g., a quantitative measurement, visual assessment, etc.) and the specific criteria are not detailed in the document.

8. The sample size for the training set:

Not Applicable. This is not an AI device, so there is no training set in the machine learning sense.

9. How the ground truth for the training set was established:

Not Applicable. As above, no training set for an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The HHS logo is a symbol of an eagle.

Procare Industrial Co., Limited c/o Jonathan Hu Technical Manager Gebiao Standard (Shanghai) Yangpu District Liaoyuan East Road Shangyang First Suite No.33 Room 303 Shanghai, 200093 CN CHINA

November 1, 2024

Re: K162917

Trade/Device Name: Allerhope® Allergy Skin Tester Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Jonathan Hu:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 17, 2017. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480. David.Wolloscheck@fda.hhs.gov.

Sincerely,

David Wolloscheck -S

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2017

Procare Industrial Co., Limited % Jonathan Hu Technical Manager Gebiao Standard (Shanghai) Yangpu District Liaoyuan East Road Shangyang First Suite No.33 Room 303 Shanghai, 200093 CN

Re: K162917

Trade/Device Name: Allerhope® Allergy Skin Tester Regulation Number: N/A Regulation Name: N/A Regulatory Class: Unclassified Product Code: LDH Dated: July 15, 2017 Received: July 18, 2017

Dear Jonathan Hu:

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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162917

Device Name Allerhope® Allergy Skin Tester

Indications for Use (Describe)

The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/1 description: The image contains the logo for Procare Industrial Co., Limited. The logo features a stylized blue cross with several blue dots clustered near the top right quadrant. To the right of the cross is the company name, "Procare Industrial Co., Limted," written in a simple, sans-serif font, also in blue. The overall design is clean and corporate, suggesting a company in the healthcare or industrial sector.

Date Prepared: Aug 8th, 2017

510(k) Summary

[As required by 21 CFR 807.92]

1. Submitter's Information

Name of Sponsor:	Procare Industrial Co., Limited
Address:	No. 5-2-9-160, Science Avenue 89, Hi-Tech ZoneZhengzhou, Henan, China
Contact Name:	Wang Yanhong
Telephone No.:	+86-13673363790
Fax No.:	+86-371-56663999
Email Address:	allergypricktest@aliyun.com

2. Correspondent's Information

Company Name:	Gebiao Standard (Shanghai)
Correspondent Name:	Jonathan HU
Telephone No.:	+86-15618986636
Email Address:	hfk1102@163.com

3. Trade Name, Common Name, Classification

Trade Name:	Allerhope ® Allergy Skin Tester
Common Name:	Allergy Skin Tester
Mode Name:	PROSPT, PROSPT II
Regulation Classification	N/A
Product Code:	LDH
Classification Panel:	General Hospital
Device Class:	Unclassified

4. Identification of Predicate Device(s)

The identified predicate within this submission is as follows:

The Multi-Test II of Lincoln Diagnostics, Incorporated have been cleared by FDA through 510(k) No. K961918 (Decision Date - Aug 7, 1996).

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Image /page/5/Picture/1 description: The image shows the logo for Procare Industrial Co., Limted. The logo consists of a blue medical cross with a cluster of blue dots near the top right quadrant. The text "Procare Industrial Co., Limted" is written in a blue sans-serif font to the right of the cross.

5. Description of the Device

6. Indication for Use

The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.

7. Technological Characteristics

The working situation and environment of Allerhope O Allergy Skin Tester is the same as that of the Multi-Test II of Lincoln Diagnostics, the technological characteristics of this product is designed to make same as that of the equivalence product. A comparison of technological characteristics is provided in the following table:

TechnologicalCharacteristics	Subject Device	Predicate Device
Product Code	LDH	LDH
Intended Use	The Allergy Skin Tester is forthe percutaneous administrationof diagnostic allergenic extracts.	The sole indication for Multi-Test II is for the percutaneousadministration of diagnosticallergenic extracts.
Product Structure	Multiple heads and points	Multiple heads and points
Material for TesterBody	Acrylic plastic(PMMA)	Acrylic plastic(PMMA)
Color Additive	Titanium dioxide	Titanium dioxide
Sterilization Method	Gamma sterilization	EO sterilization
Packaging Method	Sterilization Pouch	Sterilization Pouch

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510(k) Submission

Image /page/6/Picture/1 description: The image contains a logo for Procare Industrial Co., Limited. The logo features a blue cross-like symbol with rounded edges, accompanied by a cluster of small blue circles near the top-left corner. To the right of the symbol, the text "Procare Industrial Co., Limted" is written in a simple, sans-serif font, with the company name spread across two lines.

8. Discussion of Non-clinical Testing

The Allerhope ® Allergy Skin Tester has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which are demonstrated in the table below:

Characteristic	Standards Followed	Testing Conducted
Biocompatibility	ISO10993-5:2009	In Vitro Cytotoxicity Test
	ISO10993-10:2010	Skin Sensitization TestSkin Irritation Test
	ISO10993-11:2006	Acute Systemic Toxicity Test
	USP_NF32<85>	Endotoxin Test
Sterility	ISO11737-2:2009	Sterility Test
Performance	ISO178:2010	Flexural Properties Test
	ISO180:2000	Lzod Impact Strength Test

9. Substantial Equivalence

The intended uses, the operation methods, and the product theories of the subject device and the predicate's are same.

The sterilization method is replaced by gamma radiation, and the SAL=10-6 can be assured.

Two models in submission: PROSPT and PROSPT II have applied the structure of heads with points which is same as the predicate.

A comparison test over allergenic extracts delivery function has been conducted between subject device and predicate device. The result shows that the subject device can carry extracts as predicate device.

It is the conclusion that such difference between the subject and the predicate do not affect any of the intended use as the predicate device. And it is substantially equivalent to predicate devices in design, function, materials, operational principles and intended use.

10. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Procare Industrial Co., Limited concludes that Allerhope®Allergy Skin Tester is substantially equivalent to predicate device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).