(44 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No.
This device is an introducer sheath kit, which is used for the introduction of pacing leads or catheters, not for providing therapy itself.
No
The device is an introducer sheath kit designed to facilitate the insertion of pacing leads or catheters, which are therapeutic or interventional devices, not diagnostic ones.
No
The device description clearly lists multiple hardware components including a sheath, dilators, guidewire, syringe, needle, and optional insertion tube and stabilizer.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the introduction of pacing leads or catheters into the body during medical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) application.
- Device Description: The components described are all designed for accessing and navigating within the body (sheath, dilator, guidewire, needle, etc.). There are no components or descriptions related to testing biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device is clearly intended for a surgical or interventional procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.
The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.
Product codes
DYB
Device Description
The components of the SafeSheath MSP™ Introducer Kit consists of a sheath with sideport tubing, stopcock and heomostasis valve. The distal end of the sheath may be configured for a straight sheath or with a curve. The sheath length must be able to provide a conduit from the insertion site to the epicardial target sites.
A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.
A standard vessel dilator that will assist in insertion.
A .035" x 135 cm guidewire.
A standard 12cc syringe.
A 18 gauge XTW introducer needle.
A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,
A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.
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
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
Thomas Medical Products qualification testing of the SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve consisted of dimensional, visual, leak testing, Valve Body to Stopcock pull test and PVC Tubing to Valve Housing Peel test. All samples passed the protocol qualification testing requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
III.
510(k) SUMMARY (as required by 807.92(c))
SafeSheath MSPTM Introducer Kit
A.
· 510(k) Notification
Page 1 of 3
510(k) SUMMARY
(As required by 21 C.F.R. 807.92)
AUG 29 2012
Submitter Information
Submitter's Name: Address:
Telephone Number: Facsimile: Contact Person: Title: Date Submission Prepared:
Device Information B.
Trade name:
Classification Names: Predicate Devices:
Device Description:
Thomas Medical Products, Inc. 65 Great Valley Parkway Malvern, PA 19355 (610) 296-3000 (610) 296-4591 Peter J. Rapp Director, Quality Assurance/Regulatory Affairs November 30, 2000
SafeSheath MSP™ Introducer Kit with Integral Hemostasis Valve Catheter Introducer
Tearaway Sheath Introducer Set with Integral Hemostatis Valve (K934901)
The components of the SafeSheath MSP™ Introducer Kit consists of a sheath with sideport tubing, stopcock and heomostasis valve. The distal end of the sheath may be configured for a straight sheath or with a curve. The sheath length must be able to provide a conduit from the insertion site to the epicardial target sites.
A guiding dilator will accompany the straight or curved sheath, to assist with the guiding and steering of the sheath to the intended location.
A standard vessel dilator that will assist in insertion.
A .035" x 135 cm guidewire.
A standard 12cc syringe.
A 18 gauge XTW introducer needle.
A transvalvular insertion tube, which can be used to open the hemostasis valve during insertion of delicate leads or catheters, may also be packaged with the introducer kit,
A Pacing Lead Stabilizer (PLS) that can be used to facilitate the removal of the introducer sheath, may also be packaged with the introducer kit.
The SafeSheath MSP™ Introducer Sheath Kit with Integral Hemostasis Valve is for introduction of pacing leads or catheters during pacing lead or defibrillatory catheter placement procedures.
Intended Use:
Thomas Medical Products
III- 1
1
Comparison of Required Technological Characteristics C.
All technological characteristics of the SafeSheath MSP™ Introducer Sheath Kit with Integral All technological characteristics of the Sationall MB.
Hemostasis Valve are substantially equivalent to the predicate device (K934901) including product design, packaging, sterilization, and labeling.
Substantial Equivalence D.
Thomas Medical Products considers the SafeSheath MSP™ Introducer Sheath Kit with I homas Medical I roducts oblishers tantially equivalent to the following legally marketed meegral Ticmostasis Varve to be bath Introducer Set with Integral Hemostasis Valve (K934901).
Qualification Testing E.
Thomas Medical Products qualification testing of the SafeSheath MSP™ Introducer Sheath Thomas Mechour Products qualitional, visual, leak testing, Valve Body to Kit with thegial Tremostable moraboc ock pull test and PVC Tubing to Valve Housing Peel test. All samples passed the protocol qualification testing requirements.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract 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
AUG 2 9 2012
Oscor Inc. c/o Ms. Mila Doskocil Vice President of Regulatory Affairs and Quality Assurance 3816 DeSoto Boulevard Palm Harbor, FL 34683
Re: K122084
Trade/Device Name: Introducer Set, Model Adelante-S Series Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: August 15, 2012 Received: August 17, 2012
Dear Ms. Doskocil:
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 Federal Register.
3
Page 2 - Ms. Mila Doskocil
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 (OS) 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510k Number (if known) –
Device Name: Introducer Sets, Adelante®-S Series
The introducer sets, Adelante®-S Series are intended for introduction of pacing leads or catheters into the body.
Prescription Use _ X (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Slan-Off) Division of Cardiovascular Devices
510(k) Number K122084