specialty needles – Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Device Description

Anesthesia conduction needles consist of different styles. All the needles consist of a plastic hub connected to a stainless steel cannula. Some of the needles have stylets made of the same steel whereas others have stylets made of plastic. Some of the needles have wings which can be attached to the hub for more stability depending on user procedure. The needles have been categorized as following:

Spinal Needles (Quincke)
Pencil Point Spinal Needle (Whitacre)
Epidural Needles (Tuohy & Hustead)
The differences between the styles of needles are the tip of the needle, which is either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke).
These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Specialty Needles." This document focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting results from a standalone performance study with a test set, expert adjudication, or MRMC studies for AI devices.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to product description, intended use, and a summary of tests performed to establish substantial equivalence based on material properties and functional comparisons.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available for an AI device study:

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

For a traditional medical device like these needles, "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device. The performance is reported in terms of matching key characteristics of the predicate.

Criteria (Implied for Substantial Equivalence)	Reported Device Performance (vs. Predicate Device)
Same intended use	Same intended use
Same material	Same material
Same flow rate	Same flow rate
Same bonding strength	Same bonding strength
Biocompatibility	Materials met testing requirements and found acceptable (L929 Men Elution, Kligman Maximization, Intracutaneous Injection, Systemic Injection, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay)
Technological Characteristics	Same Technological Characteristics

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

Not applicable. This is a traditional medical device (needles), not an AI device undergoing a performance study with a test set. The document refers to "testing requirements" for materials and functional characteristics for comparison to a predicate, not a clinical test set.

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 test set requiring expert ground truth for an AI device is described.

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

Not applicable. No test set requiring adjudication in the context of AI device performance is 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 (needles), not an AI-assisted diagnostic or therapeutic 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)

For the "Specialty Needles," the "ground truth" for demonstrating substantial equivalence is based on:

Predicate Device Characteristics: The established and accepted characteristics and performance of the predicate device (Exel Spinal Needle - K895771).
Standardized Material Testing: The results of the specified biocompatibility tests (L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay).
Functional Comparisons: Direct measurement and comparison of properties like flow rate and bonding strength to the predicate device.

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI device requiring a training set.

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

Not applicable. This is a traditional medical device.

Summary

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K 061394

SUMMARY

SEP - 6 2006

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SPECIALTY NEEDLE

Regulatory Affairs Contact:	Muhamad AnsariBusse Hospital DisposablesPO Box: 1106775 Arkay Dr.Hauppauge NY 11788
Telephone:	631-435-4711 Ext: 254
Fax:	631-435-2849
Date Summary prepared:	May 16, 2006
Product Trade Name:	Specialty Needles (Spinal Needle, Pencil PointSpinal Needle, Epidural Needle)
Common Name:	Anesthesia Conduction Needle.
Classification:	Class II, 21 CFR 868.5150
Product Code:	BSP
Predicate Device:	Exel Spinal Needle - (K895771)
Device Description:	Anesthesia conduction needles consist of differentstyles. All the needles consist of a plastic hubconnected to a stainless steel cannula. Some of theneedles have stylets made of the same steel whereasothers have stylets made of plastic. Some of theneedles have wings which can be attached to thehub for more stability depending on user procedure.The needles have been categorized as following:1. Spinal Needles (Quincke)

1. Pencil Point Spinal Needle (Whitacre)
1. Epidural Needles (Tuohy & Hustead)

. .-

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The differences between the styles of needles are the tip of the needle, which is either pencil-point-tip (Whitacre), curved and sharp needle (Touhy), sharp needle tip (Quincke).

Needle Style	Gage Size Range	Length Range
Spinal Needle (Quinke)	18g to 25g	1 ½" to 6"
Pencil Point Spinal Needle(Whitacre)	18g to 25g	1 ½" to 6"
Epidural Needle (Tuohy, &Hustead)	16g to 25g	1 ½" to 6"

These needles will be provided as sterile, single use, disposable devices. They will be packaged individually or included in regional anesthesia trays.

Intended Use:

Specialty needles (Spinal Needle, Pencil Point Needle, and Epidural Needle) are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay

These materials have met the testing requirements and were found to be acceptable for the intended use.

Summary of tests performed to prove the substantial equivalence of the Specialty Needles with the predicate device:

1. Same intended use
1. Same material
1. Same flow rate
1. Same bonding strength

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Technological Characteristics:
[21 CFR 807.92(a)(6)]	The subject device has the same Technological Characteristics as a legally marketed predicate device.
Conclusion:
[21 CFR 807.92(b)(3)]	The above statements are accurate representations of the device Busse intents to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted.
Manufacturer:	Busse Hospital Disposables.
Official Correspondent:

Muhamad Ansari Date: ________________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing service and protection. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive P.O. Box 11067 Hauppauge, New York 11788-0920

Re: K061394

Trade/Device Name: Specialty Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: August 25, 2006 Received: August 28, 2006

Dear Mr. Ansari:

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.

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Page 2 - Mr. Ansari

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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FDA 510(k) Premarket Notification Busse Hospital Disposables - Specialty Needles

INDICATIONS FOR USE

510(k) Number (if known): _________

Device Name: Specialty Needles.

, t

Indication for Use: specialty needles – Spinal Needle, Pencil Point Needle, and Epidural Needle - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.

Prescription Use × (Per 21 CFR 801Subpart D) AND/OR

Over-The-Counter Use_ (Per 21 CFR 801Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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on Sign-Of
don of Anesthesiology, General Hospital,
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Number: K061394

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).