B. Braun Medical Inc. intends to introduce into interstate commerce the Blunt Syringe Cannula. These have the same design and performance characteristics as the InterLink Syringe Cannnula currently marketed by Becton Dickinson and covered under K920422. It is also similar to McGaw's SafeLine System covered under K913177. The intended use is to be used with a syringe to pierce a pre-split rubber injection site.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Blunt Syringe Cannula." It focuses on demonstrating substantial equivalence to already marketed devices, rather than establishing specific performance acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, many of the requested elements for a study proving device adherence to acceptance criteria are not applicable to this type of regulatory submission. The submission relies on comparative claims and standard manufacturing/release testing.

Here's an breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Same design and performance characteristics as predicate devices.	"These have the same design and performance characteristics as the InterLink Syringe Cannula..."
Intended Use Equivalence: Used with a syringe to pierce a pre-split rubber injection site.	"The intended use is to be used with a syringe to pierce a pre-split rubber injection site."
Material Equivalence: Equivalent materials to predicate device.	"The Blunt Syringe Cannula is equivalent in materials..."
Biocompatibility: Meet recommendations in the Tripartite Guidance for contact duration.	"B. Braun Medical certifies that the biocompatibilty tests 'recommended... will be completed for all the materials..."
Safety and Effectiveness: No new issues of safety or effectiveness compared to predicate devices.	"There are no new issues of safety or effectiveness raised by the Blunt Syringe Cannula."
Manufacturing Release Specifications: Sterility, pyrogenicity, physical testing, visual examination.	"All finished products are tested and must meet all required release specifications before distribution... include... sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product)."
Physical Testing: Conform to product design specifications.	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The submission does not describe a test set or study of this nature. The "testing" referred to is manufacturing quality control and comparison to existing predicate devices.

3. 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. No external expert panel was used to establish ground truth for a clinical test set.

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

Not Applicable. No external adjudication method for a test set was described.

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

Not Applicable. This is a physical medical device (cannula), not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device.

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

The "ground truth" in this context is the performance and characteristics of the predicate devices (InterLink Syringe Cannula K920422 and SafeLine System K913177), as well as established industry standards and regulatory requirements for medical devices (e.g., sterilization, biocompatibility, physical integrity for the stated use).

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI/machine learning study for this device. The "training" for the device's design implicitly comes from existing medical device design principles and predicate devices.

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

Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary of the "Study" (or justification) for K971924:

The provided document describes a 510(k) Premarket Notification submission for the Blunt Syringe Cannula. The "study" proving the device meets acceptance criteria is fundamentally a comparative analysis and declaration of compliance with manufacturing standards, rather than a clinical trial or performance study as might be seen for a novel therapeutic or diagnostic device.

The core argument for acceptance is substantial equivalence to predicate devices already on the market (K920422 and K913177). The manufacturer asserts that the Blunt Syringe Cannula has the "same design and performance characteristics" and is "equivalent in materials, form, and intended use" to these predicate devices. Furthermore, they state that "There are no new issues of safety or effectiveness raised."

In addition to this comparative claim, the document mentions adherence to routine quality control and manufacturing release specifications, including:

Sterility
Pyrogenicity (endotoxin/LAL Method)
Physical testing (defined by Quality Control Test Procedure documents which conform to product design specifications)
Visual examination (in process and finished product)

They also certify that biocompatibility tests "recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used."

Essentially, the device is deemed to meet acceptance criteria because it is demonstrated to be fundamentally the same in function and safety as existing, approved devices, and it will undergo standard rigorous manufacturing quality control.

Summary

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K971924

May 20, 1997

SEP 2 5 1998

II 510 (k) Summary

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

Requlatory Affairs Manager Mark S. Alsberge, CONTACT:

PRODUCT NAME: Blunt Syringe Cannula

TRADE NAME: Blunt Syringe Cannula

CLASSIFICATION NAME:

General Hospital Class II,FMF, Piston Syringe 21 CFR. 880.5860

SUBSTANTIAL EQUIVALENCE, TO:

510 (k) number	Name	Applicant
K920422	InterLink SyringeCannula	Becton Dickinson, Inc.
K913177	SafeLine System	McGaw, Inc.

DEVICE DESCRIPTION:

The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without

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premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.

MATERIAL:

B. Braun Medical certifies that the biocompatibilty tests 'recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used in the manufacture of the device.

SUBSTANTIAL EQUIVALENCE:

The Blunt Syringe Cannula is equivalent in materials, form, and intended use to the InterLink Syringe Cannula currently marketed by Becton Dickinson, covered under K920422. There are no new issues of safety or effectiveness raised by the Blunt Syringe Cannula.

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; sterility, pyrogenicity (endotoxin/ LAL Method), 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 GMP"s.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 25 1998

Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue Bethlehem, Pennsylvania 18018-0027

K971924 Re: Trade Name: Blunt Syringe Cannula Regulatory Class: II Product Code: FMI Dated: August 26, 1998 Received: Auqust 31, 1998

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. ਬੈ 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 requlations.

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 leqally 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.qov/cdrh/dsmamain.html",

Sincerely yours,

Susan Rumm

tw 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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1497 924 510(k) Number (if known): annula Device Name: Indications For Use: presslit SafeLine pierce To be used with rubber in iction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palazzo Puccerite

(Division Sign-Off) Division of Denial. Infection Control, and General Hospital Devices

510(k) Number 4971924

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).