(30 days)
K00099
Not Found
No
The description focuses on passive field sensors detecting magnets, with no mention of AI/ML terms or data processing that would suggest such technology.
No
The device is used to locate and confirm the position of catheters during initial placement, not to treat a disease or condition. It is a diagnostic/locating tool.
No
The device is described as a "Tip Location System (TLS) Detector" that "quickly locates and confirms the position of specially designed, magnet-tipped Peripherally Inserted Central Catheters (PICCs) and Central Venous Catheters (CVCs) during initial placement." It helps to "verify placement" but "was not designed to replace conventional methods of placement verification." This indicates it's a navigational or verification tool during a procedure, not a device used to diagnose a medical condition or disease.
No
The device description explicitly states it is a "battery or line powered hand held device" and includes a "battery charger," indicating it is a hardware device, not software-only.
Based on the provided information, the Sherlock™ Tip Location System (TLS) Detector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Sherlock™ TLS Function: The Sherlock™ TLS Detector works by detecting the magnetic field of a specially designed catheter stylet within the patient's body. It does not analyze any biological specimens.
- Intended Use: The intended use is to locate and confirm the position of a catheter during placement, which is an in-vivo procedure, not an in-vitro analysis of a sample.
Therefore, the Sherlock™ TLS Detector falls under the category of an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriate caregivers in hospitals, long-term care facilities or home-care settings.
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
Bench testing was performed for accuracy, which met accuracy claim, and user interface, which met requirements.
Key Metrics
Not Found
Predicate Device(s)
K00099, Zortran Detector
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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 Pestka | |||
| Lucent Medical Systems, Inc. | ||||
| 811 Kirkland Ave, Suite 100 | ||||
| Kirkland, 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
1
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
2
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
3
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
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