(241 days)
Not Found
No
The device description details a simple mechanical needle for delivering anesthetics or placing catheters. There is no mention of any computational or algorithmic components, let alone AI/ML.
No
This device is a needle used for the delivery of anesthetics and placement of epidural catheters, which are tools used in therapeutic procedures but are not therapeutic devices themselves.
No.
The device is described as an anesthesia needle intended for the transient delivery of anesthetics or to facilitate the placement of an epidural catheter, which are therapeutic and procedural functions, not diagnostic.
No
The device description clearly outlines physical components like a luer hub, stainless steel cannula, and stylet, indicating it is a hardware medical device.
Based on the provided text, 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 direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a needle used for injecting substances into the body and facilitating catheter placement. This aligns with a surgical or procedural device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
IMD's specialty / anesthesia needles - Tuohy, Quincke and Pencil Point Needles - 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 a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief.
The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are single use, sterile and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional anesthetist
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)
Not Found
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
K670354 Page 10
Image /page/0/Picture/1 description: The image shows the text "OCT 5, 2007". The text is written in a simple, sans-serif font. The letters are all capitalized, and the numbers are written in a standard format. The text is slightly blurry, but it is still legible. The text appears to be a date.
Revised Pages 3-1 - 3-2, September 20, 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Submitted By: IMD INC. P O Box 510 560 S. Highway 39 Huntsville UT 84317 (800)-824-8223, or (801) 745-4700
- Walter Zohmann, President Contact: IMD INC. P O Box 510 560 S. Highway 39 Huntsville UT 84317 (800)-824-8223, or (801) 745-4700
Device Name:
TradeNames: IMD's Tuohy needle: Quincke needle; Pencil Point needle Common Names: Anesthetic conduction needles, epidural/spinal needles
Classification Name: Anesthesia conduction needles (Reference 21 CFR 868.5150)
Product Class: Class II
Product Code: BSP
Preparation date of summary: January 22, 2007
Predicate Devices:
- Busse Hospital Disposables, Inc. Specialty Needles (Spinal Needle, Pencil Point 2.1 ... ), K061394, 09/06/2006;
- 2.2 Pajunk GMBH's Tuohy Needles, Quincke Needles, ... , K040965, 09/07/2004:
- 2.3 IMD's Anesthetic Needle (Gertie Marx), K931644, 09/22/1993,
Device Description:
Anesthesia conduction needles consist of a luer hub, a stainless steel cannula with various tip types, and a stainless steel stylet. These needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space for longer pain relief.
1
K070354 Page 2 of 2
Revised Pages 3-1 - 3-2, September 20, 2007
The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are single use, sterile and latex-free medical devices for transient delivery of anesthetics during regional anesthesia. The cannula is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for regional anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.
Intended Use:
IMD's specialty / anesthesia needles - Tuohy, Quincke and Pencil Point Needles - are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
Technology Characteristics:
The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - have the same technological characteristics as the predicate devices identified above. The IMD anesthesia conduction needles - Tuohy, Quincke, and Pencil Point - are equivalent in design physical dimensions, luer hub, metal and plastics materials, and packaging to the IMD anethesia needle (Gertie Marx)® cleared under 510(k) number K931644. They differ only in tip configurations.
Biocompatibility and sterilization are equivalent to to the IMD anethesia needle Gertie Marx)® cleared under 510(k) number K931644, since the materials, packaging, and sterilzation processes are the same.
Conclusion:
The majority of anesthesia conduction needles are pre-amendment devices, due to the fact that they have been available to anesthesiologists for about 100 years. These devices have a long history of safe use in the clinical environment. The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized abstract design, resembling a human figure or a symbol representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Walter Zohmann President International Medical Development, Incorporated 9202 Kelley Drive Post Office Box 510 Huntsville, Utah 84317
Re: K070354
Trade/Device Name: IMD's Anesthesia Needles (Tuohy, Quincke, and Pencil Point) Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: September 20, 2007 Received: September 25, 2007
OCT 5 2007
Dear Mr. Zohmann:
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. Zohmann
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) 276-0115. 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,
CARS
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):
K070354
Device Name:
IMD's Anesthesia Needles (Tuohy, Quincke, and Pencil Point)
Indications For Use:
Prescription Use
(Part 21 CFR 801 Subpart D)
IMD's specialty / anesthesia needles – Tuohy, Quincke and Pencil Point Needles – are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
XX
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concuri Degice Evaluation (ODE)
| (Division Sign-Off) |
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| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |
510(k) Number: K070354 Page 1 of 1