(110 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and basic functional performance of the needles, with no mention of AI or ML capabilities.
Yes.
The needles are used for the 'transient delivery of anesthetics to provide regional anesthesia', which is a therapeutic intervention.
No
Explanation: The device description states its intended use is for the "transient delivery of anesthetics" or to "facilitate placement of an epidural catheter." This is a therapeutic and interventional purpose, not a diagnostic one.
No
The device description clearly outlines physical components made of plastic and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details needles used for injecting substances into the body or facilitating catheter placement. This aligns with a medical device used in a clinical procedure, not a device used to examine specimens from the body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is used in vivo (inside the body) for a therapeutic/procedural purpose.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
BSP
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).
Spinal Needle (Quinke) - Gage Size Range: 18g to 25g, Length Range: 1 ½" to 6"
Pencil Point Spinal Needle (Whitacre) - Gage Size Range: 18g to 25g, Length Range: 1 ½" to 6"
Epidural Needle (Tuohy, & Hustead) - Gage Size Range: 16g to 25g, Length Range: 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Same intended use
- Same material
- Same flow rate
- Same bonding strength
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K 061394
SUMMARY
SEP - 6 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SPECIALTY NEEDLE
| Regulatory Affairs Contact: | Muhamad Ansari
Busse Hospital Disposables
PO Box: 11067
75 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 Point
Spinal 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 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)
. .-
1
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:
-
- Same intended use
-
- Same material
-
- Same flow rate
-
- Same bonding strength
2
| 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: ________________________________________________________________________________________________________________________________________________________________________
3
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.
4
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
5
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)
Salcom
on Sign-Of
don of Anesthesiology, General Hospital,
otion Control, Dental Devices
Number: K061394