(146 days)
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.
Anesthesia conduction needles consist of different styles. All the needles consist of a plastic or K-Resin 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: 1. Spinal Needles (Quincke) 2. Pencil Point Spinal Needle (Whitacre) 3. Epidural Needles (Tuohy & Hustead) The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)
The provided text describes a 510(k) premarket notification for "Specialty Needles" by Busse Hospital Disposables. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of device performance as one might expect for a diagnostic or AI-based medical device.
Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission strategy is to show the new device is as safe and effective as a device already on the market, not to establish new performance metrics through clinical trials.
Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available or not applicable for this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility: Materials are safe for intended use. | All materials used met testing requirements (Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test) and were found acceptable. |
| Intended Use: Matches predicate device. | Same intended use as the predicate device (transient delivery of anesthetics for regional anesthesia or epidural catheter placement). |
| Material Composition: Similar to predicate device. | Same material with the exception of the needle hub. |
| Flow Rate: Similar to predicate device. | Same flow rate as the predicate device. |
| Bonding Strength: Similar to predicate device. | Same bonding strength as the predicate device. |
| Technological Characteristics: Similar to predicate device. | Has the same Technological Characteristics as a legally marketed predicate device. |
2. Sample size 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. The document refers to "biological qualification safety tests" and "tests performed to prove the substantial equivalence," but does not provide numbers of devices or subjects tested.
- Data Provenance: Not specified. This would typically be internal laboratory testing results, not clinical data from a specific country.
- Retrospective or Prospective: Not applicable in this context. These are engineering and biocompatibility tests, not clinical studies.
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)
- Number of Experts: Not applicable. The "ground truth" for these types of tests is typically established by laboratory standards and established test methodologies, not expert consensus on interpretations.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for material or mechanical performance tests.
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
- MRMC study: No, this is not an AI-based device or a diagnostic imaging device. An MRMC study was not performed.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a physical medical device (anesthesia needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the biocompatibility tests (Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test), the "ground truth" is adherence to established biological safety standards and pass/fail criteria for these specific tests. For the functional characteristics (flow rate, bonding strength), the ground truth is likely measured values compared against specifications or the predicate device's performance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
{0}------------------------------------------------
busse
Hospital Disposables
73222
APR - 9 2008
.
| 510(k) SUMMARY OF SAFETY AND EFFECTIVENESSSPECIALTY 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 Revised: | April 4, 2008 |
| Product Trade Name: | Specialty Needles (Spinal Needle, Pencil Point,Epidural Needle) |
| Common Name: | Anesthesia Conduction Needle. |
| Classification: | Class II, 21 CFR 868.5150 |
| Product Code: | BSP |
| Predicate Device: | Busse Spinal Needle - (K061394) |
| Device Description: | Anesthesia conduction needles consist of differentstyles. All the needles consist of a plastic or K-Resin 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 beattached to the hub for more stability depending onuser procedure.The needles have been categorized as following:1. Spinal Needles (Quincke)2. Pencil Point Spinal Needle (Whitacre)3. Epidural Needles (Tuohy & Hustead) |
The differences between the styles of needles are the tip of the needle, which is pencilpoint-tip (Whitacre), curved and sharp needle (Toulty) or sharp needle tin (Quincke)
| Needle Style | Gage Size Range | Length Range |
|---|---|---|
| Spinal Needle (Quinke) | 18g to 27g | 1 ½" to 6" |
| Pencil Point Spinal Neede(Whitacre) | 18g to 27g | 1 ½" to 6" |
| Epidural Needle (Tuohy, &Hustead) | 16g to 25g | 1 ½" to 6" |
1 of 2
,
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo features the word "busse" in a bold, sans-serif font, with each letter slightly overlapping the next. Below the word "busse" are the words "Hospital Disposables" in a smaller, sans-serif font. The entire logo is in black and white.
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.
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 Elution Test, Systemic Injection Test, Rabbit Pyrogen Test, Intracutaneous Injection Test, Kligman Maximization Test.
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 with exception of needle hub
-
- Same flow rate
-
- Same bonding strength
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.
K073222(2 of 2)
{2}------------------------------------------------
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2008
Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788
Re: K073222
Trade/Device Name: Specialty Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: March 5, 2008 Received: March 10, 2008
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.
{3}------------------------------------------------
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sudie Y. Micham MD
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
{4}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): _ K073222
Device Name: Specialty Needles.
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 X (Per 21 CFR 801Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Min Threlfal
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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).