IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.

Device Description

The IMPROVACUTER® Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.

AI/ML Overview

The provided text describes a 510(k) submission for the IMPROVACUTER® Gel & Clot Activator Tube, a medical device for blood collection, and focuses on demonstrating its substantial equivalence to a predicate device, the BD Vacutainer® Gel & Clot Activator Tube. The study outlined is a method comparison study, which is a common approach for demonstrating equivalence for in vitro diagnostic (IVD) devices.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes the acceptance as demonstrating "no major differences" or "clinically equivalent" results compared to the predicate device. The performance is summarized qualitatively.

Criterion Type	Acceptance Criterion (Implicit)	Reported Device Performance
Clinical Equivalence	The IMPROVACUTER® Gel & Clot Activator Tube should provide clinically equivalent chemistry and immunology analyte results compared to the predicate BD Vacutainer® tubes.	"The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes." "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (This statement is repeated for Method Comparison, Stability, Shelf-life, Same-Lot Repeatability, and Lot-to-Lot Reproducibility studies)
Analyte Stability (Refrigerated)	Analytes should be stable for 24 hours at 2-8°C.	Demonstrated for all analytes. "All results showed no significant different from BD Vacutainer® stored under the same condition." and "Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL."
Analyte Stability (Room Temperature)	Analytes should be stable for 24 hours at 22-25°C.	Demonstrated for most analytes. "TBIL is stable at room temperature for up to 20 hours." and "All results showed no significant different from BD Vacutainer® stored under the same condition."
Shelf-life	The device should not show significant differences from newly manufactured devices over its shelf life.	"All results showed no significant different from these [newly manufactured devices]."
Same-Lot Repeatability	No major differences from the method comparison study results within the same lot.	"All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance).
Lot-to-Lot Reproducibility	No major differences from the method comparison study results across different lots.	"All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance).

The document refers to CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline Second edition, which would contain the specific statistical methods and criteria (e.g., allowable total error, bias, correlation coefficients) used to determine "no major differences" or "clinically equivalent." However, these specific numerical criteria are not detailed in the provided summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The exact number of individual patient samples (N) for the "clinical evaluations" (method comparison studies) is not explicitly stated in the provided text. It mentions comparing devices "in total 28 chemistry assays and 13 Immunology assays," but this refers to the number of analytes tested, not the number of samples.
Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "Clinical evaluations were performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the context of this device and study. The "ground truth" for these types of studies (blood collection tubes for chemistry and immunology assays) is based on the analytical measurements from a legally marketed and accepted predicate device, rather than expert judgment or interpretation of images/clinical findings. The "truth" is the measured analyte concentration.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system, especially in image interpretation tasks. For a method comparison study of blood collection tubes, the "readings" are objective laboratory measurements, so there is no human interpretation or adjudication process in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of a diagnostic aid (often AI) on human reader performance, usually in image-based diagnostics. This submission is for a blood collection device, which is an in vitro diagnostic (IVD) rather than an AI-powered diagnostic imaging tool. The study compares the performance of the device itself to a predicate device, not the performance of human readers using or not using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, effectively. The "clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube" by comparing its analytical results directly to those obtained from the predicate device. This is a standalone performance assessment of the device (or the "algorithm" in the context of a non-AI device, meaning its functional performance) without human interpretation influencing the primary outcome measures (i.e., analyte concentrations). The device itself is the "algorithm" being evaluated.

7. The Type of Ground Truth Used

The "ground truth," in this context, is the analyte concentration obtained from the legally marketed predicate device (BD Vacutainer® tubes). The study design is a method comparison where the predicate device serves as the reference standard. The results from the IMPROVACUTER® tubes are compared against the results from the BD Vacutainer® tubes to demonstrate "no major differences" or "clinical equivalence."

8. The Sample Size for the Training Set

Not applicable. This submission is for a traditional medical device (blood collection tube), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The device's performance is inherent to its design and materials, not learned from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary

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Image /page/0/Figure/1 description: The image contains a logo for "IMPROVE MEDICAL" in black font. The logo includes a stylized graphic element to the left of the text. To the right of the logo, there is a table with the word "Gua" at the top and the number "510" below it.

Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER* Evacuated Blood Collection Tubes

Attachment V 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.

The Assigned 510(k) Number is: K093910

Date Prepared: 05 JUL 2010

1. Sponsor Information

Guangzhou Improve Medical Instruments Co., Ltd. No.102 Kaiyuan Road, Guangzhou Science Park Hi-Tech Industries Development Zone Guangzhou City, Guangdong, China 510663 Tel: +86-20-8158 5255 Fax: +86-20-8158 7533 http://www.improve-medical.com Contact Person: Bonford Sun, Quality Manager Email: qd9@improve-medical.com

Submission Correspondent

Ms. Diana Hong, General Manager Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Zhongshan Road (S-2) Shanghai, 200030, China.

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Image /page/1/Figure/0 description: The image shows a logo with the word "IMPROVE" in bold, italicized letters. To the right of the word "IMPROVE" is a graphic. Below the graphic and to the right of the word "IMPROVE" is the text "IMPROVE MEDICAL". The text is in a smaller font than the word "IMPROVE".

Guangzhou Improve Medical Instruments Co., Ltd.

510 (K) Submission for IMPROVACUTER " Evacuated Blood Collection Tubes

3. Proposed Device Identification

Devicc Name: IMPROVACUTER® Gel & Clot Activator Tube Specifications: 13 x 75 mm / 13 x 100 mm Draw Volume: 3-5 ml for both specifications Classification Name Classification: Class II Product Code: JKA Regulation Number: 21 CFR. 862.1675

4. Device Description

5. Intended Use

6. Predicate Device Identification

BD Vacutainer® Gel & Clot Activator Tube (plastic) 510(k) Number: K023075.

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IMPROVE IMPROVE MEDICAL

Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER® Evacuated Blood Collection Tubes

7. Substantial Equivalence

Based on a comparison of the features, materials and intended use, the IMPROVACUTER® Gel & Clot Activator Tube are substantially equivalence to the commercially available predicate devices. The only difference between the predicate and the IMPROVACUTER® Gel & Clot Activator Tube is the performance claim not for Therapeutic Drug Monitoring (TDM). SE comparison information is presented below:

ITEM	Proposed Device	Predicate Device
	IMPROVACUTER® Gel & ClotActivator Tube	BD Vacutainer® Gel & Clot ActivatorTube (plastic)K023075
Intended Use	IMPROVACUTER Gel & ClotActivator Tube is a single use tubeused to collect, transport, separate, andprocess venous blood specimens toobtain serum for clinical chemistryand immunology assays. It is used insettings where a venous blood sampleis collected by a trained healthcareworker. For in vitro diagnostic use.	The BD Vacutainer® Tube is a evacuatedblood collection tube that provides ameans of collecting, transporting,separating, and processing blood in aclosed tube. Blood collected in aVacutainer® Tube is primarily used forclinical laboratory testing in chemistryusing patient serum, but may be used forother assays requiring serum specimens asdetermined by the laboratory. In addition,the Vacutainer® Tube is compatible withmany commonly used therapeutic drugstherefore suitable for therapeutic drugmonitoring (TDM).
Tube Dimension	13 x 75 mm13 x 100 mm	13 x 75 mm
Draw Volume	3-5 ml	3.5 ml
Closure	Conventional Rubber Closure	SAME
Clot Activator	Silica	SAME
Tube Shelf Life	12 months	SAME
Sterility	Sterilized	SAME
Package	Plastic film barrier bag in cardboardshelf carton.	SAME

Table 7-1 Similarities and differences table between your predicate and your candidate devices

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Image /page/3/Figure/0 description: The image contains the logo for Improve Medical. The logo includes the text "IMPROVE" in bold, along with Chinese characters and the text "IMPROVE MEDICAL". To the right of the logo is the text "Guang" and "510 (K) S".

Guangzhou Improve Medical Instruments Co., Ltd. 510 (K) Submission for IMPROVACUTER Evacuated Blood Collection Tubes

8. Synopsis of Test Methods and Results

Method Comparison Studies

Clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube. The devices were compared to the prodicate BD Vacutainer® tubes in total 28 chemistry assays and 13 Immunology assays. The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes.

All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.

Stability Studies

Studies were conducted to compare fresh specimens.24 hours stored both at 2-8℃ and at 22-25°C. All results showed no significant different from BD Vacutainer® stored under the same condition.

Analyte stability testing has been conducted for all the analytes listed. Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL. TBIL is stable at room temperature for up to 20 hours.

All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.

Shelf- life Studies

The shelf life studics are to research whether the IMPROVACUTER® Gel & Clot Activator Tube have significant difference from the ones which had just been manufactured. All results showed no significant different from these.

All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.

Same-Lot Repeatability Study

This test is intended to test IMPROVACUTER® Gel & Clot Activator Tube. whose lots are the same to those of products used in Method Comparison Study. Compare the test results with those of Method Comparison Study to determine whether there are major differences.

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Image /page/4/Picture/15 description: The image shows a logo with the word "IMPROVE" in bold, italicized letters. To the right of the word is a symbol and the Chinese characters for "Yangsen Medical". Below the Chinese characters are the words "IMPROVE MEDICAL" in smaller, non-italicized letters. The logo appears to be for a medical company.

Guangzhou Improve Medical Instruments Co., Ltd.

510 (K) Submission for IMPROVACUTER* Evacuated Blood Collection Tubes

All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.

Lot-to-Lot Reproducibility Study

Select 2 lots from both materials of normally produced IMPROVACUTER® Gel & Clot Activator Tube, and compare the test results with those of Method Comparison Study to determine whether there are major differences.

All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes.

Standard/ Guidance Document Referenced

ア CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline Second edition.
ア CLSI H18-A3: Procedures for the Handling and Processing of Blood Specimens; Approved Guideline
ﺮ CLSI H1-A5: Evacuated Tubes and Additives for Blood Specimen Collection, Approved Standard -Fifth Edition
ﺮ CLSI H3-A6: Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, Approved Standard -Fifth Edition
V ANSI/AAMI/ISO 11137: Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Guangzhou Improve Medical Instruments Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Co., Ltd. Suite 5D, No. 19, Lane 999, Zhongshan No. 2 Road (S) Shanghai, China 200030

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUL 1 2 2010

Re: K093910

Trade Name: IMPROVACUTER® Gel & Clot Activator Tube Regulation Number: 21 CFR §862.1675 Regulation Name: Blood specimen collection devices Regulatory Class: Class II Product Codes: JKA Dated: July 05, 2010 Received: July 07, 2010

Dear Ms. Hong:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820),

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/0 description: The image shows the logo for Improve Medical. The logo includes a stylized image of a bird, along with the word "IMPROVE" in bold letters. To the right of the bird image, there are Chinese characters and the words "IMPROVE MEDICAL".

Guangzhou Improve Medical Instruments Co., Ltd.

510 (K) Submission for IMPROVACUTER® Evacuated Blood Collection Tubes

Attachment I Indication for Use

510(k) Number: K093910 Device Name: IMPROVACUTER® Gel & Clot Activator Tube

Indication for Use:

For in vitro diagnostic use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CARS

Division Sign-

Office of In Vitro Dia Device

510(k) K093910

Page 1 of 1

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.