(112 days)
The Stingray Epidural Catheter Connector is intended to provide various anesthetic and fluid administration devices with a single, common 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 consists of two molded plastic body Sections that mate in a twist and lock motion. Between the two Sections is a molded bushing that compresses and grips an epidural catheter.
This document, a 510(k) summary for the Stingray Epidural Catheter Connector, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The purpose of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, not necessarily to present a de novo study with acceptance criteria and performance data in the format requested. While it mentions "The testing performed and comparison to the predicate device demonstrates that the Stingray Epidural Catheter is safe and effective," it does not elaborate on what that testing entailed, its methodology, or its results.
Therefore, I cannot provide the requested information for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document states the device is "safe and effective" and "substantially equivalent" but provides no specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: Not present. No information about specific test sets, their size, or origin (country, retrospective/prospective) is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. This type of information is typically for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's 510(k) submission. No expert review for ground truth is mentioned.
- Adjudication method: Not applicable/present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical connector, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. The "testing performed" likely referred to bench testing or engineering evaluations to ensure physical and functional equivalence to the predicate, rather than ground truth in the context of diagnostic performance.
- The sample size for the training set: Not applicable. This device is not an AI/machine learning model that would require a training set.
- How the ground truth for the training set was established: Not applicable.
What the document does provide:
- Device Name: Stingray Epidural Catheter Connector
- Intended Use: A connection device to provide various anesthetic and fluid administration to an access point to an epidural catheter for delivery of anesthetics, used in conjunction with an epidural catheter for continuous administration of anesthetic agents.
- Predicate Device: B. Braun Medical Perifix® Catheter Connector (K032144)
- Conclusion: The device is "safe and effective and is substantially equivalent to the predicate device" based on "testing performed and comparison to the predicate device."
To obtain the detailed information requested, one would typically need to review the full 510(k) submission, which would include detailed test reports, protocols, and results. This summary, by its nature, is an abbreviated version.
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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.
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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
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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.
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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
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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.
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).