(84 days)
Not Found
No
The summary describes a catheter for administering local anesthetics and makes no mention of AI or ML capabilities, image processing, or data analysis related to AI/ML.
Yes.
The device is used for the administration of local anesthetics for pain management, which falls under therapeutic use.
No
The device is described as being for the administration of local anesthetics for pain management and regional anesthesia, not for diagnosing conditions.
No
The device description explicitly mentions physical characteristics like "closed end with multiple holes," "fenestrated area," "radiopaque," and "19g and 20g sizes," indicating it is a physical medical device, not software-only.
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 administration of local anesthetics into intra-operative sites for pain management and regional anesthesia. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter designed for delivering substances into the body. This aligns with a therapeutic or procedural device, not a device used to test samples outside the body (which is the definition of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
In summary, the device is designed for delivering medication within the body, which is a therapeutic function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The intended use of the subject device is for the administration of local anesthetics into intra-operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
The Conduction Catheter is not intended for intravenous or intra-muscular use.
Product codes
FRN
Device Description
The subject device is available as a closed end with multiple holes, fenestrated area, located radially along the lateral surface at the distal end of the device.
The subject device is radiopaque and is available in 19g and 20g sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-operative sites, outside of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991879, K001717, K003966, K003611
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
AUG 1 3 2003
MICOR, INC CONFIDENTIAL
Summary of Safety and Effectiveness 21 CFR 807.92(a)(6)
Date of preparation of Summary: May 21, 2003
MICOR Contact:
- Susan Forgrave 1.
- MICOR, INC 2. 2855 Oxford Boulevard Allison Park, PA 15101
- Telephone: 412-487-1113 3. Facsimile: 412-487-1747 E-mail: sforgrave@micorinc.com
Device Name:
- Common name Conduction Catheter 1.
- Trade name not applicable at this time 2.
- Classification Name: 3.
- Device name: Conduction catheter a.
- Speciality: Anesthesiology b.
- Product code: FRN C.
- Device class: 2 d.
- e. Regulation: 21 CFR 880.5725
Predicate Devices:
- K991879 MICOR EpiFlex Epidural Catheter 1.
- K001717 MICOR Epidural Conduction Catheter 2.
- K003966 MICOR Conduction Catheter 3.
- K003611 Pain Care Multi-Port Catheter 4.
Product Description/Function:
-
- Description:
- The subject device is available as a closed end with multiple holes, fenestrated area, a. located radially along the lateral surface at the distal end of the device.
- The subject device is radiopaque and is available in 19g and 20g sizes. b.
-
- Function:
- The fenestrated area provides the distribution of anesthetic over the surgical wound 2. sites.
- The stainless steel coil increases the flexibility and kink resistance of the catheter. ს.
Technological Characteristics:
- Technological Characteristics of the subject device are substantially equivalent to the 】. predicate devices K991879 and K003966 manufactured by MICOR, INC.
Materials:
- The polyamide co-polymer, stainless steel coil and black ink used in the subject device is ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ substantially equivelent to the materials used in the predicate devices K991879 and K003966 manufactured by MICOR, INC.
Section 7 Page 1 of 2
1
$()31600
MICOR, INC CONFIDENTIAL
Intended Use:
- The intended use of the subject device is for the administration of local anesthetics into intra-1. operative sites for post-operative pain management and for regional anesthesia outside of the epidural space. Routes of administration may be intra-operative, subcutaneous or percutaneous.
Safety and Effectiveness:
- No new issues of safety and effectiveness are raised by the design of the subject device. 』。
- The subject device is substantially equivalent in its performance to predicate K003966 and in 2. its intended use to predicates K003966 and K003611
Conclusion:
- The design, performance, materials, intended use and safety and effectiveness of the subject 1. device is substantially equivalent to the cited predicate devices.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
AUG 1 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Forgrave Quality Assurance & Regulatory Manager Micor Incorporated 2855 Oxford Boulevard Allison Park, Pennsylvania 15101
Re: K031600
Trade/Device Name: Conduction Catheter Regulation Number: 880. 5725 Regulation Name: Accessary to Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 20, 2003 Received: June 3, 2003
Dear Ms. Forgrave:
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 - Ms. Forgrave
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Quarles
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MICOR, INC CONFIDENTIAL
Indications For Use Statement 21 · I R 807.92(a)(5)
K031600 SIO(k) number(if known)
Device name: Conduction Catheter
Indications for use:
to a viet of the Cenduction Catheter is intestitution intration of local anesthetics ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ comments winters openative sites for post-operative pain management and for · regional anesthesia outside of the epidural space.
·············································································································································································· percutaneous.
. The Conduction Catheris and intended for intravenous or intra-muscular 115€.
officase domot write below this line - soutinue on another page if needed
Concurrence of CDRH Office, Office of Device Evaluation (ODE)
Prescription use
OR Over-the-Counter
Sultana Cucerant
(Division Sign-Off) Divisor of Anesthesiology Infection Control. Dent
510(k) Number: K051600
So. re: re: