The provided text describes a 510(k) submission for a medical device called "Chemo Mini Spike Plus." It outlines the device's description, materials, and substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any clinical outcomes.

The document focuses on regulatory approval based on substantial equivalence to an existing marketed device (I.V. Fluid Transfer Pin cleared under K925401).

Here's a breakdown of the requested information based on the provided text, highlighting what is not available:

Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

*The document mentions "All finished products are tested and must meet all required release specifications before distribution." And "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." However, specific quantitative or qualitative acceptance criteria (e.g., fluid flow rate, leakage rate, material strength thresholds) and the actual performance data against these criteria are not provided in this 510(k) summary.*

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size for Test Set: Not specified.
* Data Provenance: Not specified.
The document indicates "All finished products are tested," implying testing on production units, but details on sample size, origin, or study design (retrospective/prospective) are absent.

Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a component (IV additive dispensing pin) and a "ground truth" based on expert consensus for diagnostic accuracy is not relevant to its regulatory submission as described here. The evaluation is focused on manufacturing specifications and material compatibility, not diagnostic performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed for this device.
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 is not an AI/diagnostic imaging device, and no MRMC study or comparative effectiveness study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "testing required for release" and "physical testing," the ground truth appears to be the product design specifications and established testing procedures and parameters. This is a functional and material conformance "ground truth." Not a clinical or diagnostic ground truth.
The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established
- Not applicable. This device does not involve machine learning or a "training set."

Summary of the Study (as described in the document):

The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense. Instead, it refers to:

Materials Testing: "The Chemo Mini Spike Plus is composed of materials that have been tested in accordance with the EN Standard 30993 and have been determined to be suitable for the intended use of this product." This implies material biocompatibility and suitability testing.
Product Release Testing: "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
Quality Control Testing: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications."

Conclusion:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" based on materials, form, and intended use to a previously cleared predicate device, along with adherence to manufacturing quality control specifications. It does not contain the detailed performance data, acceptance criteria, study sizes, or ground truth establishment methods typically found in submissions for diagnostic or AI-enabled devices. The "study" mentioned refers to internal quality control and material testing rather than a formal clinical or in-vitro diagnostic performance study.

Summary

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3/23/99

II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

RIOF2

B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 (610)691-5400

September 28, 1998 K983794

Contact: Mark S. Alsberge, Regulatory Affairs Director

Product Name: Chemo Mini Spike Plus
Chemo Mini Spike Plus Trade Name:

Classification name:

General Hospital Class II. 80LHI 21 CFR 880.5440

SUBSTANTIAL EQUIVALENCE TO:

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4075AL		Inc

Device Description:

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Chemo Mini is an IV additive dispensing pin for aspiration from multidose containers or injection into IV systems (IV bag).

Material:

The Chemo Mini Spike Plus is composed of materials that have been tested in accordance with the EN Standard 30993 and have been determined to be suitable for the intended use of this product.

1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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Substantial equivalence:

Image /page/1/Picture/1 description: The image shows handwritten text. The first line reads "K983794". The second line reads "P. 2 of 2". The text appears to be written with a black pen on white paper.

The Chemo Mini Spike Plus is similar in materials, form and intended use to the I.V. Fluid Transfer Pin currnetly marketed by B. Braun Medical, Inc. and cleared under K925401. There are no new issues of safety or effectiveness raised by Chemo Mini Spike Plus.

Safety And Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product).

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. The eagle is facing to the right and has three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18103-9341

Re : K983794 Chemo Mini Spike Plus Trade Name: Regulatory Class: II Product Code: LHI February 10, 1999 Dated: Received: February 16, 1999

Dear Mr. Alsberge:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Alsberge

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Lumpe

&Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Plus Mini Spike lemo Device Name: Indications For Use: aspiration IV additive dispensing Ho injection containers multi-dose Ur trom sfems TV into

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltric Cucenta
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use .

(Optional Format 1-2-96)

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.