(230 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "me too" device with the same technological characteristics as predicate devices.
No
The device is used to administer anesthetic agents, which are drugs, into the epidural space. While anesthesia is part of a therapeutic process, the needle itself is an administration tool for a drug, not a therapeutic device that directly treats a condition.
No
The device is intended for the administration of anesthetic agents, not for diagnosing a condition.
No
The device description explicitly states it is a "needle" and describes physical characteristics and performance testing related to a physical object, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of anesthetic agents into the epidural space. This is a procedure performed directly on a patient's body, not on a sample of bodily fluid or tissue in vitro (outside the body).
- Device Description: The device is a needle used for injection, a physical intervention.
- Performance Studies: The performance studies mentioned are in vitro testing of the needle's physical characteristics (dimensional criteria, conformance to standards), not testing of a diagnostic assay or measurement of biological markers.
IVD devices are used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for a medical procedure, not for analyzing a sample.
N/A
Intended Use / Indications for Use
The intended use of the Lutz Needle is for the administration of single-shot epidural anesthesia.
To introduce single-shot anesthetic agents into the epidural space.
Product codes
BSP
Device Description
The needle presented in this application is equivalent to other anesthesia conduction needles on the market that have been approved for marketing through the Premarket notification process. This is a "me too" device. The subject device has the same technological characteristics as legally marketed predicate devices. The features, specifications, and mode of action are substantially equivalent.
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
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
The Lutz Needle was tested (in vitro) as follows: First article inspection for dimensional criteria and conformance to standards.
Conclusions from non-clinical data per 807.92(b)(3):
Based on the indications for use, technological characteristics and performance testing, use of the Lutz Needle for its intended use is safe and effective.
Key Metrics
Not Found
Predicate Device(s)
B. Braun Epidural Needle #K923400, Ballard Tuohy Needle #K000495
Reference Device(s)
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
KC13892
June 27, 2002 Reply to William Noe and Angela Smith, FDA
Image /page/0/Picture/3 description: The image shows the text "BALLARD" in large, bold letters, with a thick black line underlining the word. Below the line, the words "1EDICAL PRODUCTS" are printed in a smaller, sans-serif font. The text appears to be part of a logo or branding for a medical products company.
Appendix F Attachment 1.0 Revised Summary Statement
510(k) Premarket Notification Summary Statement
June 27, 2002
Submitter information per 807.92(a)(1):
Sydnee F. McMillan, RN. BSN Senior Requlatory Affairs Specialist Ballard Medical Products, a wholly owned subsidiary of the Kimberly Clark Corporation 12050 Lone Peak Parkway Draper, UT 84020 Tel. (801) 523-5295 Fax (801) 572-6869
Proprietary Name per 807.92(a)(2):
Ballard Medical Products Lutz Needle
Common name per 807.92(a)(2):
Anesthetic conduction needles
Classification per 807.92(a)(2):
Class II through the Anesthesiology Panel per 21 CFR 868.5150. Classification name: Needle, Conduction, Anesthetic (with or without introducer). Product code: BSP
Legally marketed equivalent(s) per 807.92(a)(3):
B. Braun Epidural Needle #K923400 Ballard Tuohy Needle #K000495.
Device Description:
The needle presented in this application is equivalent to other anesthesia conduction needles on the market that have been approved for marketing through the Premarket notification process. This is a "me too" device. The subject device has the same technological characteristics as legally marketed predicate devices. The features, specifications, and mode of action are substantially equivalent.
Intended use per 807.92(a)(5):
The intended use of the Lutz Needle is for the administration of single-shot epidural anesthesia.
1
June 27, 2002 Reply to William Noe and Angela Smith, FDA
Technological Characteristics (equivalence to predicate devices) per 807.92(a)(6):
The general design characteristics and function is similar in that it meets performance standards where applicable for:
Stainless steel components: ISO 9626 Hub: ISO 594 Hub-to needle bond strength: ISO 7864
Determination of substantial equivalence (non-clinical data) per 807.92(b)(1):
The Lutz Needle was tested (in vitro) as follows: First article inspection for dimensional criteria and conformance to standards.
Conclusions from non-clinical data per 807.92(b)(3):
Based on the indications for use, technological characteristics and performance testing, use of the Lutz Needle for its intended use is safe and effective.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and unity. The logo is rendered in black and white.
Public Health Service
JUL 11 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sydnee F. McMillan, RN, BSN Senior Regulatory Affairs Specialist Ballard Medical Products 12050 S. Lone Peak Parkway Draper, Utah 84020
Re: K013892
Trade Name: Lutz Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: May 6, 2002 Received: May 8, 2002
Dear Ms. McMillan:
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.
3
Page 2 - Ms. McMillan
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 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
July 9, 2002 Reply to Joanna Weitershasen, FDA
Appendix F Attachment 1.0 Device Indication for Use Statement
K013892 510(k) Number:
Device Name: Lutz Needle
Indication For Use:
To introduce single-shot anesthetic agents into the epidural space.
DO NOT WRITE BELOW THIS LINE. CONTINUE ON A SECOND PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use M
OR
Over-The-Counter Use
510(k) Number K013892