The regional anesthesia catheter securement device is a sterile single use securement device intended for securing regional anesthesia catheters at the skin insertion site to help prevent catheter migration. The maximum period of use is 7 days.

Device Description

The Lock-It™ Plus regional anesthesia catheter securement device consists of an adhesive backed polyethylene foam pad, with a clear molded plastic latch mechanism securely adhered to the top surface of the foam pad. The regional anesthesia catheter securement device is available for use with catheters using 16/17gauge needles. The regional anesthesia catheter securement device is provided individually packaged or in anesthesia conduction kits.

AI/ML Overview

The provided text describes a 510(k) submission for the Lock-It™ Plus Regional Anesthesia Catheter Securement Device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical data and a user evaluation, rather than defining and proving acceptance criteria with a detailed study.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria and a study proving those criteria, is largely absent from the document. The text does not provide quantitative acceptance criteria for device performance or a study explicitly designed to meet them.

However, based on the provided text, here is an attempt to address the requested information as much as possible:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Non-clinical:
Equivalent or superior performance to predicate device in: - Percent flow restriction - Catheter retention force - Tape adhesion force	Data submitted demonstrates that the catheter securement device performs equivalently to the predicate device.
Clinical (User Evaluation):
Equal to or better performance than a device currently sold by Smiths Medical International (UK) related to "performance characteristics" (specific characteristics not detailed).	The clinical user evaluation concluded that the proposed device was equal to or better than a device currently sold by Smiths Medical International (UK).
Securement of regional anesthesia catheters at the skin insertion site to help prevent catheter migration for a maximum period of 7 days.	"This user evaluation provided useful support that the device performs as intended." (Implicitly, this includes securement for 7 days as per indication).

Study Details

1. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified. The document only mentions a "clinical user evaluation" conducted at "three sites OUS (outside the U.S.): Royal Free Hospital, Ipswich Hospital and Lewisham Hospital." The number of patients or catheters evaluated is not provided.
Data Provenance: Prospective user evaluation conducted OUS (outside the U.S.) at Royal Free Hospital, Ipswich Hospital, and Lewisham Hospital.

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

The document describes a "clinical user evaluation," implying that the "users" (presumably healthcare professionals involved in regional anesthesia) provided feedback on performance. However, it does not specify "experts" establishing a "ground truth" in a formal sense for the test set. The evaluation compared the device to another commercially available device and gathered user feedback on performance characteristics. The qualifications of these users are not detailed.

3. Adjudication method for the test set:

Not specified. The user evaluation "inquired as to the performance characteristics" and concluded the device was "equal to or better than" the comparator. There is no mention of a formal adjudication process.

4. 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:

No. This was not an MRMC study and did not involve AI. It was a user evaluation of a physical medical device.

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

No. This device is a physical securement device, not an algorithm.

6. The type of ground truth used:

User judgment/feedback. For the clinical user evaluation, the "ground truth" was the subjective and objective assessment of the device's performance characteristics by the clinical users compared to a known device. For the non-clinical data, the "ground truth" was likely laboratory measurements of quantifiable metrics like flow restriction, retention force, and adhesion force.

7. The sample size for the training set:

Not applicable/Not specified. This was not a machine learning model, so there was no "training set."

8. How the ground truth for the training set was established:

Not applicable. See above.

Summary

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K051524

JUL - 7 2005

smiths

Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

10 Bowman Drive Keene NH 03431-0724 USA Tol: +1 603 352 3812 Fax: +1 603 352 3703 www.smilhs-medical.com

J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

COMPANY INFORMATION:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Cynthia Engelhardt Associate Regulatory Affairs Specialist

PREPARATION DATE OF SUMMARY:

June 7, 2005

TRADE NAME:

Lock-It™ Plus Regional Anesthesia Catheter Securement Device

COMMON NAME:

Accessory to Regional Anesthesia Conduction Catheter

PRODUCT CLASS/CLASSIFICATION:

Class II, 73 BSO, 21 CFR 868.5120

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PREDICATE DEVICE(S):

StatLock II Epidural Securement Device, K943038.

DESCRIPTION:

The regional anesthesia catheter securement device is available for use with catheters using 16/17gauge needles.

The regional anesthesia catheter securement device is provided individually packaged or in anesthesia conduction kits.

INDICATIONS FOR USE:

TECHNICAL CHARACTERISTICS:

The design of the proposed catheter securement device is similar to the predicate device. Both devices are designed to minimize catheter migration. Both devices are made of molded polycarbonate bonded to a foam pad. The technical characteristics of the two devices show no significant differences.

NON-CLINICAL DATA:

Data submitted demonstrates that the catheter securement device performs equivalently to the predicate device. Data submitted covers; percent flow restriction, catheter retention force and tape adhesion force.

CLINICAL DATA:

A clinical user evaluation has been conducted at three sites OUS (outside the U.S.): Royal Free Hospital, Ipswich Hospital and Lewisham Hospital. The intention of this user evaluation was not to compare the device to the predicate indicated in this 510(k) submission, rather to inquire as to the performance characteristics as compared to a device marketed by our sister company Smiths Medical International (UK) and sold exclusively to the OUS market. The clinical user evaluation concluded that the proposed device was equal to or better than a device currently sold by Smiths Medical International (UK).

This user evaluation provided useful support that the device performs as intended.

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CONCLUSION:

The comparison to the predicate device demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Cynthia Engel

Cynthia Engelhardt Associate Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2005

Ms. Cynthia Engelhardt Associate Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

Re: K051524

Trade/Device Name: Lock-It™ PLUS Regional Anesthesia Catheter Securement Device Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: June 7, 2005 Received: June 8, 2005

Dear Ms. Engelhardt:

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.

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Page 2 - Ms. Engelhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DTC issumes on that your device complies with other requirements mean that I DA nas made a autos and regulations administered by other Federal agencies. of the Act of ally I oderal battler ta requirements, including, but not limited to: registration 1 ou intist comply with and are tabeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF RePart 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadion 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) I mis letter will anon you be objections of substantial equivalence of your device to a premarket notified.com - 1110 wire 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), If you desire specific at not to for your ce at (240) 276-0120. Also, please note the regulation prease contact the Office or Occipital spremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miermational 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,

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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B: INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Lock-It™ PLUS Regional Anesthesia Catheter Securement Device

Indications for Use:

The regional anesthesia catheter securement device is a sterile single use securement device I he regional anesulesia catheter becareires at the skin insertion site to help prevent michded for socuring - ogeneralinum period of use is 7 days.

Prescription Use_ V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Aree Syleom

(Division Sigh Off) (Division Sign-Jily)
Division of Anesthesiology, General Hospital, Division of Ancolinoental Devices

510(k) Number.__

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).