(112 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is a connector for an epidural catheter, not a standalone therapeutic device itself. It facilitates the delivery of anesthetic agents, but it does not directly administer therapy or provide a therapeutic effect.
No
The device is described as a connector for epidural catheters for the administration of anesthetic agents, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of molded plastic body sections and a molded bushing, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing a common access point to an epidural catheter for the delivery of anesthetics and fluids. This is a therapeutic and drug delivery function, not a diagnostic one.
- Device Description: The description details a mechanical connector for a catheter, which aligns with its intended use for fluid administration.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
A connection device is used to provide various anesthetic and fluid administration A connection as not for to an access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents. The Stingray Epidural Catheter Connector is intended to provide various The Stingray Epidoral Catherer tonnadevices with a single, common access andsthelic and fruid administration of anesthetics. The connector point to an epidural catheter for delivery of anesolutions. is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
Device Description
The Stingray Epidural Catheter Connector consists of two molded plastic body The bungray Epitation in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Epidural
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)
The testing performed and comparison to the predicate device demonstrates that the Stingray Epidural Catheter is safe and effective and is substantially equivalent to the predicate device.
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.
B. Braun Medical Perifix® Catheter Connector (K032144)
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
KOSITY
AUG 2 6 2005
Section II
510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of QA/RA
Date Prepared:
May 4, 2005
Trade Name:
Stingray Epidural Catheter Connector
Common Name:
Anesthesia Conduction Catheter Kit
Product Class/Classification:
Class II - CAZ, 21 CFR 868.5140
Predicate Device(s):
B. Braun Medical Perifix® Catheter Connector (K032144)
Description:
The Stingray Epidural Catheter Connector consists of two molded plastic body The bungray Epitation in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.
1
Intended Use:
A connection device is used to provide various anesthetic and fluid administration A connection as not for to an access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
Comparison to Predicate:
The Stingray Epidural Catheter Connector has similar physical and technical The Stinglay Epidaran redicate device and a similar intended use to the predicate device.
Conclusion:
The testing performed and comparison to the predicate device demonstrates that the Stingray Epidural Catheter is safe and effective and is substantially equivalent to the predicate device.
Epimed International, Inc.
Chall
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
AUG 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher Lake Manager of QA/RA Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095
Re: K051171
Trade/Device Name: Stingray Epidural Catheter Connector Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: August 16, 2005 Received: August 22, 2005
Dear Mr. Lake:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to reward young determined the device is substantially equivalent (for the icitications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichuments, or to do roos and time in the Act (Act) that do not require approval of a premarket the Federal F ood, Drag, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents 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 (1 Mr), it may be sacyeet to Jack of Federal Regulations, Title 21, Parts 800 to 898. In your device can or found in further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. Lake
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease oc advisod that 1 DT o levice complies with other complies with other requirements mean that FDA has made a acessions administered by other Federal agencies. of the Act of ally I outstal buttors requirements, including, but not limited to: registration r ou must comply with and are are are any labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF R Part 807), abolity systems (QS) regulation (21 CFR Part 820); and if requirencents as set form in the quasily is a 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) This letter will and w Jowell of Job finding of substantial equivalence of your device to a premiarket notification. The PDF 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 (71 CFR Part 801), If you desire specific at no for Joiance at (240) 276-0115. 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 may obtain 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/industry/support/index.html.
Sincerely yours,
Susan Runne
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051171
Device Name: Stingray Epidural Catheter Connector
Indications For Use:
The Stingray Epidural Catheter Connector is intended to provide various The Stingray Epidoral Catherer tonnadevices with a single, common access andsthelic and fruid administration of anesthetics. The connector point to an epidural catheter for delivery of anesolutions.
is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Uuysvaorn,
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number.
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