(30 days)
The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings. The Sherlock™ Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.
The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient. The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement.
Acceptance Criteria and Device Performance for Sherlock™ Tip Location System (TLS) Detector
1. Acceptance Criteria and Reported Device Performance
The provided document indicates the following acceptance criteria and device performance:
| Characteristic Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | (Not explicitly stated, but implied to be sufficient for its intended use.) | Meets accuracy claim |
| User Interface | (Not explicitly stated, but implied to be satisfactory.) | Meets requirements |
Note: The document only provides broad statements ("Meets accuracy claim" and "Meets requirements") rather than specific quantitative acceptance criteria or numerical performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bench" testing.
3. Number of Experts Used and Their Qualifications for Ground Truth
The document does not specify the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed, nor does it provide information on human reader improvement with or without AI assistance. The device is a "Tip Location System (TLS) Detector," which sounds like a standalone device rather than an AI-assisted interpretation system for human readers.
6. Standalone (Algorithm Only) Performance
The document describes the "Sherlock™ Tip Location System (TLS) Detector" as a "battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet." This implies that the device operates as a standalone system (algorithm only) to provide rapid feedback on catheter tip location, without a human-in-the-loop for interpreting its output. The "Bench" testing for "Accuracy" and "User interface" would reflect its standalone performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the bench testing. Given that it's a "Tip Location System," the ground truth for accuracy would likely be established through precise physical measurements or imaging techniques (e.g., X-ray, fluoroscopy) to independently verify the actual position of the magnet-tipped stylet compared to the device's reading.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This suggests the device's underlying technology (passive field sensors) may not rely on machine learning or deep learning models that typically require large training datasets.
9. How Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth might have been established.
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K06/240
Sherlock™ Tip Location System (TLS) Detector 510(k) Summary (Page 1 of 1)
| Device trade name: | Sherlock™ Tip Location System (TLS) Detector | JUN - 2 2006 | ||
|---|---|---|---|---|
| Common name: | Catheter Placement Verification Device | |||
| Device class and panel: | 880.5970, Accessory to intravascular catheter, Class II | |||
| Applicant name: | Cynthia PestkaLucent Medical Systems, Inc.811 Kirkland Ave, Suite 100Kirkland, WA 98033(425) 822-3310, x33 (phone) | |||
| Predicate device(s): | K00099, Zortran Detector | |||
| Device description: | The Sherlock™ Tip Location System (TLS) Detector is a battery or line powered hand held device which detects the location of a magnet-tipped catheter stylet. A battery charger is also provided. The Sherlock™ Tip Location System (TLS) Detector uses only passive field sensors, and does not emit energy of any sort into the patient.The Sherlock™ Tip Location System (TLS) Detector is designed (and labeled) to be used only with a compatible PICC or CVC intravascular catheter stylet which contains one or more small, specially oriented magnets encapsulated at the distal end. It provides rapid feedback to a caregiver about the location and orientation of these magnet-tipped devices during initial placement. | |||
| Premarket Testing: | Type | Characteristics Tested | Results | |
| Bench | Accuracy | Meets accuracy claim | ||
| Bench | User interface | Meets requirements |
™ Sherlock is a registered trademark of Bard Access Systems
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Image /page/1/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 lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Pestka Director, Regulatory Affairs and Quality Assurance Lucent Medical Systems Incorporated 811 Kirkland Avenue, Suite 100 Kirkland, Washington 98033
Re: K061240
Trade/Device Name: Sherlock™ Tip Location System (TLS) Detector Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 2, 2006 Received: May 3, 2006
Dear Ms. Pestka:
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.
JUN - 2 2006
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Page 2 - Ms. Pestka
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 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.
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 vour 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 (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 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/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
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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Attachment #3 Statement of Intended Use
Indications for Use Statement
510(k) Number
(f known) K061240
Sherlock™ Tip Location System (TLS) Detector Device Name
Indications The Sherlock™ Tip Location System (TLS) Detector quickly locates and confirms the For Use position of specially designed, magnet-tipped Peripherally.Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement. This device may be used by appropriate caregivers in hospitals, long-term care facilities or home-care settings.
The Sherlock™ Tip Location System (TLS) Detector provides rapid feedback to the caregiver, but was not designed to replace conventional methods of placement verification. Users are urged to confirm correct placement according to their established institutional protocol and clinical judgment.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) Contray, General Hospital, on Control, Dontal Devices
**** Lucent Medical Systems Confidential ****
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”