(39 days)
Not Found
No
The device description and intended use describe a simple mechanical spinal needle with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is used to administer anesthetic agents, which are therapeutic, but it is a delivery tool, not a therapeutic device itself.
No
Explanation: The device is described as a "Spinal Needle" used for "spinal administration of anesthetic agents to provide regional anesthesia." This is a therapeutic or drug delivery device, not one that identifies or monitors a medical condition.
No
The device description explicitly details physical components (stainless steel cannula, plastic hub, stylet) and is described as a sterile, single-use, disposable device, indicating it is a hardware medical device.
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 spinal administration of anesthetic agents to provide regional anesthesia." This describes a procedure performed directly on a patient's body for therapeutic purposes (administering medication).
- Device Description: The device is a "Spinal Needle" used for insertion into the spinal canal. This is a surgical/procedural device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) outside of the body. IVDs are typically used in laboratories or point-of-care settings to diagnose or monitor conditions based on these samples.
Therefore, this device falls under the category of a medical device used for a surgical or procedural intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the spinal administration of anesthetic agents to provide regional anesthesia.
Product codes
BSP
Device Description
The Spinal Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub.
The Spinal Needle will be provided as a sterile, single use, disposable device. The Spinal Needle will be available in a variety of lengths and gauges.
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)
Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted.
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
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
JUL 3 0 2002
KOOOOOJ
Section II
510(K) Summary
Company Information:
Epimed International, Inc. PO Box 1128 Gloversville, NY 12078 (518) 725-0209 Contact: Christopher B. Lake Manager of RA/QA
Date Prepared:
June 18, 2002
Trade Name:
Spinal Needle
Common Name:
Spinal Needle
Product Class/Classification:
Class II
Predicate Device(s):
Manan Medical Products Spinal Needle (K852427)
Description:
The Spinal Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub.
The Spinal Needle will be provided as a sterile, single use, disposable device. The Spinal Needle will be available in a variety of lengths and gauges.
1
Intended Use:
For the spinal administration of anesthetic agents to provide regional anesthesia.
Comparison to Predicate:
The Spinal Needle has identical physical and technical characteristics to the Manan Medical Products Spinal Needle marketed under K852427.
Non-Clinical Data:
Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted.
Conclusion:
The comparison to the predicate device demonstrates that the Spinal Needle is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
Epimed International, Inc.
Chr.ff
Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Mr. Christopher B. Lake Manager of Regulatory Affairs & Quality Assurance Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095
Re: K022029
Trade/Device Name: Quincke Spinal Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: June 19, 2002 Received: June 21, 2002
Dear Mr. Lake:
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.
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.
Image /page/2/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.
3
Page 2 - Mr. Lake
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Tim 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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Page 1 of 1
| 510(k) Number (if known): | K022209 KO22029 |
|---|---|
| Device Name: | Spinal Needle |
Indications For Use:
For the spinal administration of anesthetic agents to provide regional anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
signature
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number -