(171 days)
K0073110, K871132
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a mechanical introducer, with no mention of AI or ML.
No.
The device is used to introduce catheters into the vascular system; it does not provide any therapy itself.
No
Explanation: The device is described as an introducer for catheters into the vascular system, facilitating insertion rather than providing diagnostic information or measurements.
No
The device description clearly details physical components (dilator, peelable sheath, hubs, valve) made of specific materials (PEBAX, polyethylene, polycarbonate, silicone) and provides physical dimensions (French sizes, diameters, lengths). This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of catheters into the vascular system. This is a procedural device used for accessing the body, not for testing samples taken from the body.
- Device Description: The description details a physical device (dilator and sheath) used for a physical procedure (inserting a catheter). There is no mention of reagents, assays, or analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
- Use in a laboratory setting
The device is clearly intended for direct use on a patient to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system.
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Each Smiths Medical Peel-Away Sheath Introducer consists of a dilator and a peelable sheath. Both the dilator and the sheath have a hub at the proximal end. The dilator slides inside the sheath and the hubs are engaged so that sheath and dilator may be manipulated as a single unit. One version of the Smiths Medical Peel-Away Sheath Introducer has a valve on the proximal end of the hub.
The introducers are available in French sizes ranging from 6 to 11. Interior diameters of the sheath range from .085 to .147 inches. Outside diameters range from .116 to .182 inches. The length of the dilator for the non-valved introducer is nominally 8 inches from hub to tip with a 6 inch sheath. The dilator for the valved introducer is 7 inches long with a 5 inch sheath.
The Peel-Away Sheath Introducer is used to facilitate the insertion of a catheter into the vascular system by dilating a vessel and introducing the sheath. The hubs are then disengaged and the dilator is removed leaving the sheath through which a catheter may be inserted. The sheath hubs are then broken and the sheath is peeled away and removed from the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, subclavian vein
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)
The non-clinical testing included assessment of the physical properties of the Peel-Away Sheath Introducer and its compatibility with co-packaged accessories. Biocompatibility assessment of the device was performed on the materials used to construct the introducers. The materials used in the introducer include PEBAX, polyethylene and polycarbonate. The valve used on valved introducers is made of silicone. The device is biocompatible based on the testing of the materials and reinforced by a history of use in the medical device industry.
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Smiths Medical Peel-Away Sheath Introducer. Bench tests have confirmed compatibility with common accessories and conformance with specifications.
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.
K0073110, K871132
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
§ 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
Summary Page 1 of 3 K112407 510(k) Number:_
Date Prepared August 18, 2011
Submitter Information
| Submitter's Name: | Smiths Medical ASD, Inc. |
|---|---|
| Address: | 1265 Grey Fox Road |
| St. Paul, MN 55112 |
Establishment Registration: 2183502
| Contact Person: | Thomas Bliss
Sr. Regulatory Affairs Specialist |
|-----------------|---------------------------------------------------|
| | Phone: (651) 628-7145
Fax: (651) 628-7457 |
Device Information
| Trade Name: | Smiths Medical Peel-Away Sheath Introducers |
|---|---|
| Common Name: | Introducer Sets |
| Classification Name: | Catheter Introducer |
| Product Code: | DYB |
| Regulation: | 21 CFR 870.1340 |
Predicate Device(s)
The predicate devices are the currently marketed Adelante® Brand Introducers manufactured by Oscor, Inc. and Smiths Medical Subclavian Introducer Sets.
The reference 510(k) numbers for these devices is provided below:
1
Summary Page 2 of 3 510(k) Number:
| Predicate Device | 510(k) |
|---|---|
| Adelante® Introducer Set Models: Adelante® and Adelante® S-Lite | K0073110 |
| Smiths Medical Subclavian Introducers | K871132 |
Device Description
Each Smiths Medical Peel-Away Sheath Introducer consists of a dilator and a peelable sheath. Both the dilator and the sheath have a hub at the proximal end. The dilator slides inside the sheath and the hubs are engaged so that sheath and dilator may be manipulated as a single unit. One version of the Smiths Medical Peel-Away Sheath Introducer has a valve on the proximal end of the hub.
The introducers are available in French sizes ranging from 6 to 11. Interior diameters of the sheath range from .085 to .147 inches. Outside diameters range from .116 to .182 inches. The length of the dilator for the non-valved introducer is nominally 8 inches from hub to tip with a 6 inch sheath. The dilator for the valved introducer is 7 inches long with a 5 inch sheath.
The Peel-Away Sheath Introducer is used to facilitate the insertion of a catheter into the vascular system by dilating a vessel and introducing the sheath. The hubs are then disengaged and the dilator is removed leaving the sheath through which a catheter may be inserted. The sheath hubs are then broken and the sheath is peeled away and removed from the catheter.
Indications for Use
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the vascular system.
2
Summary of Non-Clinical Testing
The non-clinical testing included assessment of the physical properties of the Peel-Away Sheath Introducer and its compatibility with co-packaged accessories. Biocompatibility assessment of the device was performed on the materials used to construct the introducers. The materials used in the introducer include PEBAX, polyethylene and polycarbonate. The valve used on valved introducers is made of silicone. The device is biocompatible based on the testing of the materials and reinforced by a history of use in the medical device industry.
Summary of Clinical Testing
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the Smiths Medical Peel-Away Sheath Introducer.
Statement of Equivalence
The Smiths Medical Peel-Away Sheath Introducer is identical to the currently marketed Adelante® and Adelante® S-Lite Introducer and is packaged with accessories and in configurations substantially equivalent to the Subclavian Introducer currently marketed by Smiths Medical.
Conclusion
Based on the indications for use, technological characteristics, materials of construction, configuration and packaging, the proposed Smiths Medical Peel-Away Sheath Introducer is Substantially Equivalent to the identified predicate devices. Bench tests have confirmed compatibility with common accessories and conformance with specifications.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 09 2012
Smiths Medical ASD, Inc. c/o Mr. Thomas Bliss Senior Specialist Regulatory Affairs 1265 Grey Fox Road St. Paul, MN 55112
K112407 Re:
Trade Name: Smiths Medical Peel-Away Sheath Introducers Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: February 2, 2012 Received: February 6, 2012
Dear Mr. Bliss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premained 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 commerce prior in May 20, 1970, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval opp and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, dierelore, market the Act include requirements for annual registration, listing of general controls provisions of the 1.67 labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Trease note: CDFC. Coos not on the truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (see acove) into views affecting your device can be may be subject to additional controlly " and thing and 800 to 898. In addition, FDA may louid in the Code of reach. Nogancerning your device in the Federal Register.
4
Page 2 - Mr. Thomas Bliss
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 that I Dri has made a and regulations administered by other Federal agencies. You must or any I court statures and including, but not limited to: registration and listing comply war an all als not to the Part 801); medical device reporting (reporting of medical (21 CFR 807); accemes (21 CFR 803); good manufacturing practice requirements as set device-related adverse events) (2) OFF Part 820); and if applicable, the electronic ion in the quality systems (Sections (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 IT you desire specific advice for your comters offices/CDRH/CDRHOffices/ucm115809.htm for go to mig.//www.ida.gov.rroodiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" note the legulation entitled, "Misolanding of reference vents under the MDR regulation (21 CFR Part 803), please go to
regulation (21 CFK Pat 803), picase 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 You may obtain outch general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 036-2041 of (501) 7700 vices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M. A. Hilleben
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification
Indications for Use Statement
K112407 510(k) Number:
Desice Name: Smiths Medical Peel-Away Sheath Introducers
Indications for Use:
The Smiths Medical Peel-Away Sheath Introducers are indicated for the introduction of catheters into the subclavian vein. ...
Prescription Use X (Per 21 CFR 801 .109)
AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.L. Killebrew
(Division Sign-Off) Division of Cardiovascular Devices
K112407 510(k) Number_