(29 days)
Not Found
No
The device description and performance studies focus on mechanical securement and physical properties, with no mention of AI/ML terms or functionalities.
No.
The device is a securement device intended to prevent catheter migration, not to treat a medical condition or disease.
No
Explanation: The device is a securement device used to prevent catheter migration, not to diagnose a medical condition. Its function is purely mechanical.
No
The device description clearly outlines physical components (adhesive backed polyethylene foam pad, clear molded plastic latch mechanism) and performance studies focus on physical properties (flow restriction, retention force, adhesion force), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "regional anesthesia catheter securement device intended for securing regional anesthesia catheters at the skin insertion site to help prevent catheter migration." This is a physical device used externally on the body to secure a medical tube.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples from the patient. Its function is purely mechanical securement.
Therefore, this device falls under the category of a general medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BSO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin insertion site
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)
Non-clinical data 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.
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.
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.
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
§ 868.5120 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).
0
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 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.
INDICATIONS FOR USE:
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.
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.
2
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.__
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