The PeriFuse™ regional anesthesia Catheter is indicated for use during procedures where intermittent administration of local anesthetics is indicated for control of operative, postoperative, acute or chronic pain for peripheral nerve block procedures. The duration of use should not exceed 72 hours.

Device Description

The PeriFuse™ Catheter is an echogenic regional anesthesia catheter intended to enhance visibility of the catheter under ultrasound guidance. The PeriFuse™ Catheter is made of flexible nylon tubing and comes in two versions. One version is a closed end with 3 lateral eyes. The second version is an open end with a finished tip. The catheters are available as 21G (O.D. 0.83mm nominal/I.D. 0.41mm nominal) and have a nominal length of 944mm. They will be provided as sterile, single use, disposable devices. The PeriFuse™ Catheter tip is marked for ease of identification and to ensure complete catheter removal. The catheter is extruded using a patented Smiths Medical technology which leaves a surface finish that is slightly textured on both the inner diameter and outer diameter. The PeriFuse™ Catheter may be packaged in either a catheter kit or may be included in Smiths Medical regional anesthesia trays (K965017).

AI/ML Overview

The provided text describes a 510(k) submission for the PeriFuse™ Catheter and explicitly states that no clinical data was required for this submission. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses entirely on non-clinical data to establish substantial equivalence to predicate devices. The non-clinical testing conducted included mechanical, functional, and performance evaluations, demonstrating compliance with "stated sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use."

Since no clinical study was performed, most of the requested information regarding acceptance criteria, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable based on the provided document.

Here's an attempt to fill in the table and address the questions based solely on the information given, highlighting what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Mechanical Performance	Met requirements of stated sections of BS 6196:1989	PeriFuse™ Catheter meets the requirements of the stated sections of BS 6196:1989
Functional Performance	Met requirements of stated sections of BS 6196:1989	PeriFuse™ Catheter meets the requirements of the stated sections of BS 6196:1989
General Performance	Met requirements of stated sections of BS 6196:1989	PeriFuse™ Catheter meets the requirements of the stated sections of BS 6196:1989
Substantial Equivalence to Predicate Devices	Similar technological characteristics to predicate devices (nylon catheters, 21G, closed end 3 eye or open end no eye design, styleted version)	The comparison to the predicate catheter devices demonstrates that the proposed PeriFuse™ Catheter is safe and effective and is substantially equivalent to the predicate catheter devices.
Ultrasound Visibility	Incorporated a bubbling technology to enable visible under ultrasound guidance (referenced by Wallace SureView™ technology)	The proposed PeriFuse™ Catheter incorporates a bubbling technology to enable the catheter to be visible under ultrasound guidance. (Acceptable use of this technology in medical devices shown by reference to K033084).

2. Sample size used for the test set and the data provenance

Not Applicable (N/A). No clinical test set or data provenance from a clinical study is mentioned. Non-clinical testing was performed, but specific sample sizes for these tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No ground truth established by experts for a clinical test set is mentioned.

4. Adjudication method for the test set

N/A. No clinical test set or adjudication method is mentioned.

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

N/A. No MRMC study performed. The device is a medical catheter, not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. The device is a medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance evaluation, the "ground truth" was compliance with specified sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use. This standard itself would define the performance metrics and acceptable ranges.
For substantial equivalence, the "ground truth" was the technological characteristics and indications for use of the predicate devices.

8. The sample size for the training set

N/A. No training set for an algorithm is applicable.

9. How the ground truth for the training set was established

N/A. No training set for an algorithm is applicable.

Summary

{0}------------------------------------------------

smiths medical

bringing technology to life

Smiths Medical ASD Inc. 10 Bowman Drive Keene, NH 03431, USA T: +1 603 352 3812 F: +1 603 355 8157 www.smiths-medical.com

SECTION 5, 510(k) Summary

Company Information:

Smiths Medical ASD, Inc. 10 Bowman Dr Keene, NH 03431 (781)763-9404 Contact: Christine Lloyd Regulatory Affairs Specialist Summary Prepared: June 28, 2012

Product Name:

Trade Name: PeriFuse™ Catheter Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit, (21 CFR 868.5140, Product Code CAZ)

V121525

Predicate Device(s):

Primary Predicate K001129, ProLong® Regional Anesthesia Catheter, Model PL50, PL100, PL150 Secondary Predicate K994275, SIMS Portex Anesthesia Catheter

Reference Device(s):

K033084, Wallace (SureView™) Embryo Replacement Catheters & Trial Transfer Catheters

Device Description

The PeriFuse™ Catheter tip is marked for ease of identification and to ensure complete catheter removal. The catheter is extruded using a patented Smiths Medical technology which leaves a surface finish that is slightly textured on both the inner diameter and outer diameter

AUG 2 2012

{1}------------------------------------------------

The PeriFuse™ Catheter may be packaged in either a catheter kit or may be included in Smiths Medical regional anesthesia trays (K965017).

Indications for Use:

Technological Characteristics:

The proposed device and the predicate devices are nylon catheters for regional . anesthesia use for peripheral nerve blocks.
. Both the proposed and predicate devices are 21G catheters,
Both the proposed and predicate catheters are closed end 3 eye design. ●
Both the proposed and secondary predicates are open ended, no eye design, .
The proposed PeriFuse™ Catheters are available in a styleted version the same as the . secondary predicate catheters.
The proposed PeriFuse™ Catheter incorporates a bubbling technology to enable the . catheter to be visible under ultrasound guidance. The reference devices, the Wallace (SureView™) Embryo Replacement Catheters & Trial Transfer Catheters, are provided to show the acceptable use of this technology in medical devices. This patented technology is used in the cleared Wallace (SureView™M) Embryo Replacement Catheters to enable the physician to guide the catheter into the proper position in the uterus to properly place the viable embryo into position during reproductive procedures.

All statements and representations set forth herein regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration (FDA), and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).

{2}------------------------------------------------

Non-Clinical Data:

Non-clinical testing for the PeriFuse™ Catheter has been conducted including mechanical, functional and performance. The PeriFuse™ Catheter meets the requirements of the stated sections of BS 6196:1989 Sterile epidural catheters and introducer needles for single use.

Clinical Data:

Not required.

Conclusion:

The comparison to the predicate catheter devices demonstrates that the proposed PeriFuse™ Catheter is safe and effective and is substantially equivalent to the predicate catheter devices.

Sincerely,
Christie Lloyd
SMITHS MEDICAL ASD, INC.

Christine Lloyd Regulatory Affairs Specialist

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 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" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Christine Lloyd Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

Re: K121525

Trade/Device Name: PeriFuse™ Catheter Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 22, 2012 Received: May 23, 2012

Dear Ms. Lloyd:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.

AUG 2 2012

{4}------------------------------------------------

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

SECTION 4, Indications for Use Statement

Indications for Use

K121525 510(k) Number (if known):

Device Name: PeriFuse™ Catheter

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

. 510(k) Number: . .

Regulation Number and Section

§ 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).