(44 days)
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 20 - 24 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 20 - 24 gauge Perifix catheters for continuous administration of anesthetic agents.
The Perifix Catheter Connector is a connecting device used to connect an anesthesia conduction catheter (most commonly an epidural or nerve block catheter) to a luer device for the administration of anesthetic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in 510(k) K022019. The second configuration is cleared in the 510(k) K032144. This 510(k) submission is to expand the indications for use for the first configuration to include the 24 Ga. Perifix catheter.
The Perifix Catheter Connector is approximately 1.77 inches long and 0.43 inches in diameter. The connector consists of a luer device on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism.
The provided document is a 510(k) premarket notification for a medical device called the "Perifix® Catheter Connector." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies. Therefore, it does not contain the kind of detailed study information (like sample sizes, expert qualifications, or multi-reader studies) typically found for devices requiring more rigorous validation.
Here's the breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for a study. The primary "criterion" for this 510(k) submission is to demonstrate substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K022019) | The device (Perifix® Catheter Connector) is substantially equivalent to its predicate. The only change is a material change to the compressible catheter channel due to a supplier reformulation. This change does not raise new issues of safety or efficacy, allowing for expanded indications for use. |
| Intended Use: Connection to 20-24 gauge Perifix catheters | The device is used to provide various anesthetic and fluid administration devices with a single, common access point to 20-24 gauge Perifix catheters for continuous administration of anesthetic agents. This expands the original indication to include 24 Ga. Perifix catheters. |
| Safety and Efficacy (no new issues) | The applicant states that the minor material change "does not raise any new issues of safety or efficacy." |
2. Sample size used for the test set and the data provenance
No test set or clinical study data is reported in this 510(k) summary. The submission focuses on a minor design change (material reformulation) and expanded indications, relying on the substantial equivalence to a previously cleared device. Therefore, there's no information about sample size or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no test set or clinical study data is presented, there is no mention of experts or ground truth establishment.
4. Adjudication method for the test set
Not applicable. No test set is described.
5. 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 medical connector, not an AI or imaging device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission is the established safety and efficacy of the predicate device and the assessment that the minor change does not alter this.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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FEB - 4 2004
7.0 510(k) Summary
. .
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2597Contact: Amy Smith, RA Specialist |
|---|---|
| DEVICE NAME: | Perifix® Catheter Connector |
| COMMON OR USUALNAME: | Anesthesia Catheter Connector |
| DEVICECLASSIFICATION: | Class II per Code of Federal Regulations, Title 21, § 868.5120 -Anesthesia Conduction Catheter, 868.5140 - AnesthesiaConduction Catheter Kit |
| PREDICATE DEVICE: | B. Braun Medical Inc.; Perifix Catheter Connector; K022019 |
| DESCRIPTION: | The Perifix Catheter Connector is a connecting device used toconnect an anesthesia conduction catheter (most commonly anepidural or nerve block catheter) to a luer device for theadministration of anesthetic fluids. Catheter connectors arecommonly used in epidural anesthesia kits and nerve block kits.The Perifix Catheter Connector will be available in two differentconfigurations. The first configuration is the one cleared in 510(k)K022019. The second configuration is cleared in the 510(k)K032144. This 510(k) submission is to expand the indications foruse for the first configuration to include the 24 Ga. Perifix catheter.The Perifix Catheter Connector is approximately 1.77 inches longand 0.43 inches in diameter. The connector consists of a luerdevice on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism. |
| INTENDED USE: | A connection device used to provide various anesthetic and fluidadministration devices with a single, common access point to 20 -24 gauge Perifix catheter for delivery of anesthetics. Theconnector is used in conjunction with 20 - 24 gauge Perifixcatheters for continuous administration of anesthetic agents. |
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SUBSTANTIAL EQUIVALENCE:
The Perifix® Catheter Connector indications for use cleared in K022019 are being revised to include use with a 24 Ga. Perifix catheter. The only change to this device is a change to the material of the compressible catheter channel. This change was made due to a reformulation by the supplier. This minor change does not raise any new issucs of safety or efficacy.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
B. Braun Medical Incorporated Amy Smith, RAC Regulatory Affairs Specialist MFG. DIV. 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K033952
Trade/Device Name: Perifix Catheter Connector Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSO Dated: December 19, 2003 Received: December 22, 2003
Dear Ms. Smith:
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 Medica 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 regulytions affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
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Page 2 - Ms. Smith
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 sct 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) 594-4646. 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,
Chuls
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
Enclosurc
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2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Perifix® Catheter Connector Device Name:
Indications For Use:
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 20 - 24 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 20 - 24 gauge Perifix catheters for continuous administration of anesthetic agents.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Usc
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(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Device
510(k) Number: K033752
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§ 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).