BIOTEQ® SCALP VEIN SET (BS-120 (22G); BS-121(23G) ; BS-122(24G))consist of the following 5 major components: Protective cap for needle, the stainless needle, the plastic butterfly wing , the PVC Tube, the PVC safety Cap. These 5 major components assembled together as SCALE VEIN SET for use as a pathway to administer medical fluid from extracorporeal system through the device into venous blood.

AI/ML Overview

The provided text is a 510(k) summary for the BIOTEQ® SCALP VEIN SET. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Instead, the submission relies on demonstrating substantial equivalence to already approved predicate devices through bench testing that confirms physical, chemical, biological, and sterilization specifications.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as this is not the type of study described.

Here's a breakdown of the information that is available based on your request:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as stated or implied)
Physical Specification	Conforms to applicable standards (not explicitly detailed)
Chemical Specification	Conforms to applicable standards (not explicitly detailed)
Biological Specification	Conforms to applicable standards, including ISO 10993 series & USP Pyrogenic standards
Sterilization Specification	Conforms to applicable standards, including ISO 11607-1, ISO 11135
Intended Use	Serves as a pathway to administer parenteral fluid/medication into the patient's vascular system.
Technological Characteristics	Similar to predicate devices; bench testing shows no new safety/effectiveness questions.

Study Details (Based on available information)

Sample size used for the test set and the data provenance: Not explicitly stated as a "test set" in the context of an AI/diagnostic device. The "bench testing" likely refers to laboratory-based evaluations of the device's components and assembled product against engineering and safety standards. The provenance (e.g., country of origin, retrospective/prospective) for this bench testing is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a device like a scalp vein set, "ground truth" typically relates to objective measurements against established engineering and safety standards, rather than expert interpretation of data.
Adjudication method for the test set: Not applicable. No human interpretation or adjudication process is described for this type of bench testing.
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: Not applicable. This document pertains to a medical device (scalp vein set), not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ISO, USP), and functional performance requirements for medical devices of this type. It's objective, measurable criteria rather than subjective expert consensus or clinical outcomes data in the typical sense.
The sample size for the training set: Not applicable. This is not a machine learning device, so there is no training set.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

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K012526

SEP 1 4 2001

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

BIOTEQUE CORPORATION Submitter's Name: 1. Suite 402, 4th Fl, No. 136, Sec.3,Jen-Ai Road, Taipei, R.O.C. Address: 886-2-2708-6716 Phone: 886-2-2707-6610 Fax: Mr. William Lee (General Manager) Contact:

Device Name 2. BIOTEQ® SCALP VEIN SET Trade Name: SCALP VEIN SET Common Name: SET, ADMINISTRATION, INTRAVASCULAR Classification name:

Class II Classification: 3.
TERUMO SURFLO WINGED INFUSION SET (K771204) Predicate Device: র্ণ, EXEL BUTTERFLY SCALP VEIN SET (K862491)

BIOTEQ® SCALP VEIN SET (BS-120 (22G); BS-121(23G) ; Device Description: રું. BS-122(24G))consist of the following 5 major components: Protective cap for needle, the stainless needle, the plastic butterfly wing , the PVC Tube, the PVC safety Cap. These 5 major components assembled together as SCALE VEIN SET for use as a pathway to administer medical fluid from extracorporeal system through the device into venous blood.

BIOTEQ® SCALP VEIN SET act as a pathway to administer parenteral Intended Use: ર. fluid/ medication into the patient's vascular system.

Performance Summary: In terms of Physical specification, Chemical specification, Biological specification & Sterilization Specification, the device conforms to applicable standards included ISO 10993 series, ISO 11607-1, ISO 11135, USP Pyrogenic standards & related standards -- -- etc.

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Conclusions: 8.

The BIOTEQ® SCALP VEIN SET have the same intended use and similar technological characteristics as the TERUMO SURFLO WINGED INFUSION SET ( K771204 ) & EXEL BUTTERFLY SCALP VEIN SET (K862491). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the BIOTEQ® SCALP VEIN SET is substantially equivalent to the predicate devices.

Page 2 of 2

FDA 510(K) SUMMARY

Page Revision

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2001

C/O Mr. Allen Reich Consultant BioTeque Corporation 900 N. Switzer Canyon Drive #142 Flaggstaff, Arizona 86001

Re: K012526

Trade/Device Name: BioTeque Scalp Vein Set Regulation Number: 880.5440 Regulation Name: Scalp Vein Set Regulatory Class: II Product Code: FPA Dated: July 31, 2001 Received: August 6, 2001

Dear Mr. Reich:

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 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.

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Page 2 - Mr. Reich

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); 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 (section 531-542 of the Act; 21); CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski

Direttor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page -1 of 1

510 (k) NUMBER (IF KNOWN): K012526

BIOTEQ® SCALP VEIN SET DEVICE NAME: BIOTEQUE CORPORATION

INDICATIONS FOR USE:

BIOTEQ® SCALP VEIN SET act as a pathway to administer parenteral fluid/ medication into the patient's vascular system.

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

Concurrence of CDRH, Office of Device Evaluation Prescription Use Over-The-Counter X OR (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.