(386 days)
Not Found
No
The summary provides no information suggesting the use of AI/ML, and the device description and intended use are consistent with a traditional medical device for nerve stimulation.
Yes
The device is used for continuous nerve block anesthesia or analgesia, which are therapeutic medical interventions.
No
Explanation: The device is a nerve stimulating catheter used for continuous nerve block anesthesia or analgesia, not for diagnosing medical conditions. It delivers stimulation, rather than collecting or analyzing data to identify a disease or condition.
No
The device description and intended use clearly describe a physical catheter, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to place catheters next to nerves for continuous nerve block anesthesia or analgesia. This is a therapeutic procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: While the description is "Not Found," the intended use clearly indicates a device used in vivo (within the living body), not in vitro (in glass/outside the body).
- Anatomical Site: The anatomical site is "nerves and nerve plexus," which are internal structures of the body.
Therefore, the Pandin Continuous Nerve Stimulating Catheter is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves and nerve plexus
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): 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
§ 868.5140 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
SEP - 9 2003
Image /page/0/Picture/1 description: The image shows a handwritten number, which appears to be 'K022752'. The numbers are written in a cursive style, with some connections between the digits. The writing is in black ink on a white background, and the image is clear and easy to read.
HDC Corporation's Pandin Continuous Nerve Stimulating Catheter 510(k) Summary
| Name of Device: | Pandin Continuous Nerve Stimulating Catheter |
|---|---|
| Common or Usual Name: | Continuous Nerve Stimulating Catheter |
| Classification Name: | Kit, Conduction Anesthetic |
| CFR Section: | 868.5140 |
| Product Codes: | CAZ |
| Submitter: | |
| HDC Corporation | |
| 628 Gibraltar Court | |
| Milpitas, CA 95035 | |
| Phone: | (408) 942-7340 |
| Facsimile: | (408) 586-8680 |
| Contact Person: | Earl Smart |
| Date Prepared: | 08\06\02 |
| Predicate Devices: |
Intended Use:
StimuCath Continuous Nerve
Block Set
The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.
Neurotrac
(Neuro-Trace)
CLA Kit (Nerve
Block Infusion)
1
Substantial Equivalence:
All predicate devices presented for comparison with the Pandin™ Continuous Nerve Stimulating Catheter are single patient, single use, intended to facilitate the placement of a Peripherally Inserted Conductive Catheter for regional nerve block procedures. Additionally the Pandin™ Continuous Nerve Stimulating Catheter is used procedurally the same as the StimuCath™ (K021567) and contains the identical Tuhoy needle used in the CLA™ kit (K994059).
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2003
Mr. Earl Smart Quality Assurance Manager HDC Corporation 628 Gibraltar Court Milpitas, California 95035
Re: K022752
Trade Name: Pandin Continuous Nerve Stimulating Catheter Regulation Number: 868.5140 Regulation Name: Kit, Conduction Anesthetic Regulatory Class: II Product Code: CAZ Dated: June 12, 2003 Received: June 13, 2003
Dear Mr. Smart:
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. Earl Smart
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 (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 vour 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) 594-4646. 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 Punges
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
4
Indications for Use Statement
| 510(k) Number | K022752 |
|---|---|
| Device Name | Pandin Continuous Nerve Stimulating Catheter |
| Indications for Use The Pandin TM Continuous Nerve Stimulating Catheter permits placement o |
f catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-tne-counter Use
Q. Autoch for JXH 9/9/03
510(k) Number: K022752
000110