(27 days)
No
The 510(k) summary describes a mechanical medical device (needle set/kit) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
Explanation: The device is a needle set/kit used for anesthesia procedures, not for treating a disease or condition, which is the definition of a therapeutic device.
No
The device is used to perform a medical procedure (combined spinal/epidural anesthesia), not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like stainless steel, polypropylene, and rubber, 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 to "perform the combined spinal/epidural (CSE) anesthesia procedure." This is a medical procedure performed on a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The description details the physical components of a needle set/kit used for administering anesthesia. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of diagnostic or monitoring purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool used for a medical procedure.
N/A
Intended Use / Indications for Use
The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to perform the combined spinal/epidural (CSE) anesthesia procedure.
Product codes
73 CAZ, BSP
Device Description
A comparison between the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit and existing BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit is provided in the table below:
| COMPONENT /
CHARACTERISTIC | CSE
(EXISTING DESIGN) | CSE
(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Cannula | Stainless Steel | Stainless Steel |
| Needle Hub | Polypropylene | Polypropylene |
| Stylet | Polypropylene | Polypropylene |
| Color Additive | Pink/Gray | Pink/Gray |
| Gasket | None | Isobutyl Rubber |
| Needle Shield | Polyethylene | Polyethylene |
| Locking
Mechanism | Slide/Grip Lock | Pinch Lock |
| Sterilization
Process | ETO | ETO |
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
KO125884
1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com
SEP = 6 2001
Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of a stylized sun-like symbol on the left and the letters "BD" in bold, sans-serif font on the right. The sun-like symbol features a central circle with radiating lines, resembling a person with outstretched arms.
Indispensable to human health
Summary of Safety and Effectiveness for the BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit
-
1 BD Contact person:
Pasquale Amato Regulatory Compliance Coordinator BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847- 4513 (201) 847- 4855 Fax -
Device Name: BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit 2
-
Predicate Device(s): 3
- 3.1 BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit K945497.
-
Intended Uses: The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used 4 to perform the combined spinal/epidural (CSE) anesthesia procedure.
-
Device Description and Comparison: ട്
A comparison between the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit and existing BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit is provided in the table below:
| COMPONENT /
CHARACTERISTIC | CSE
(EXISTING DESIGN) | CSE
(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Cannula | Stainless Steel | Stainless Steel |
| Needle Hub | Polypropylene | Polypropylene |
| Stylet | Polypropylene | Polypropylene |
Summary of Safety and Effectiveness
1
| COMPONENT /
CHARACTERISTIC | CSE
(EXISTING DESIGN) | CSE
(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Color Additive | Pink/Gray | Pink/Gray |
| Gasket | None | Isobutyl Rubber |
| Needle Shield | Polyethylene | Polyethylene |
| Locking
Mechanism | Slide/Grip Lock | Pinch Lock |
| Sterilization
Process | ETO | ETO |
-
Equivalence determination: 6
The modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is substantially The modified DD Durasale - Place are the existing unmodified predicate equivalent in product lances! Epidural Lock CSE Needle Set/Kit exhibits the following similarities as detailed below: -
Same intended use .
-
Similar confirmation of needle placement .
-
Same range of needle gauge sizes .
-
Similar insertion technique .
-
Same materials .
-
Same sterilization process .
In summary the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit in Juminary the mountssion is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized representation of a human figure. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Mr. Pasquale Amato BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417
Re: K012584
BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit Regulation Number: 868.5140/868.5150 Regulation Name: Anesthetic Conduction Kit/Anesthesia Conduction Needle Regulatory Class: II (two) Product Code: 73 CAZ/BSP Dated: August 9, 2001 Received: August 10, 2001
Dear Mr. Amato:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 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. Pasquale Amato
In addition, we have determined that your device kit contains Povidine Iodine Solution and Xylocaine (Lidocaine) 1 percent which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
This letter will allow you to begin marketing your device as described in your 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 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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"(21 CFR 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Qallertell
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2
Indications for Use Statement
510(k) Number: not known at this time
Device Name: BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit
Indications for Use: The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to perform the combined spinal/epidural (CSE) anesthesia procedure.
Oalle Hill
Division of Cardiovascular & Respiratory Devices
510(k) Number RO12584
prescription use ✓