(136 days)
No
The summary describes a physical guiding sheath and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a guiding sheath for introducing other interventional and diagnostic devices, not providing therapy itself.
No
The device is a guiding sheath used for the introduction of other interventional and diagnostic devices, but it does not perform diagnostic functions itself.
No
The device description clearly states it is a physical guiding sheath made of materials like coil reinforcement and has a radiopaque tip, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The R2P™ Destination Slender™ Guiding Sheath is a physical device used to facilitate the introduction of other medical devices into the body (in vivo) during interventional and diagnostic procedures in the peripheral vasculature. It acts as a conduit or guide.
- Intended Use: The intended use clearly states it's for "introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site." This is a procedural tool, not a diagnostic test performed on a sample.
The description and intended use align with a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including but not limited to the radial artery.
Product codes
DYB
Device Description
The R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities of the peripheral vasculature
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)
Performance testing was conducted to ensure that the R2P™ Destination Slender™ Guiding Sheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
The R2P™ Destination Slender™ Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed R2PTM Destination Slender™ Guiding Sheath is substantially equivalent.
This 510(k) does not include data from clinical tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
October 5, 2017
Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921
Re: K171491
Trade/Device Name: R2PTM Destination Slender™ Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 6, 2017 Received: September 7, 2017
Dear Liang Lu:
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.
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 of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171491
Device Name
R2PTM Destination Slender™ Guiding Sheath
Indications for Use (Describe)
R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K171491 510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by:
Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079
Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Registration Number: 2243441
Manufacturer (510(k) Applicant)
Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880
Sterilization Facility
Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552
Contact Person: Liang Lu
Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com
Date prepared: May 11, 2017
4
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2PTM Destination Slender™ Guiding Sheath |
|---|---|
| Common Name: | Guiding Sheath |
| Classification Name: | Catheter Introducer |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed are:
- . Primary Predicate Device: K052185 - Destination Carotid Guiding Sheath, manufactured by Terumo Medical Corporation, USA
- Reference Device: K161546 R2P SlenGuide, manufactured by Terumo . Corporation
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the R2P™ Destination Slender™ Guiding Sheath, manufactured by Terumo Medical Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
The R2PTM Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated and is available in 6Fr with a length of 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.
F. INDICATIONS FOR USE (807.92(a)(5))
R2P™ Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including but not limited to the radial artery.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The R2PTM Destination Slender™ Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device, manufactured by Terumo Medical Corporation.
5
Image /page/5/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word.
A comparison of the technological characteristics is summarized on the table below.
| Device
Characteristic | New Device:
R2PTM Destination
Slender™ Guiding
Sheath | Primary Predicate:
Destination Carotid
Guiding Sheath
(K052185) | Reference Device:
R2P SlenGuide
(K161546) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical
Corporation | Terumo Medical
Corporation | Terumo Corporation |
| Intended Use /
Indications for
Use | R2PTM Destination
Slender™ Guiding
Sheath is indicated to
be used for the
introduction of
interventional and
diagnostic devices in
the lower extremities of
the peripheral
vasculature through an
access site, including
but not limited to the
radial artery. | The Destination®
Guiding Sheath is
designed to be used for
the introduction of
interventional and
diagnostic devices into
the human vasculature
including but not
limited to the carotid
arteries. | The R2P (radial to
peripheral)
SlenGuide is
designed for the
introduction of
interventional and
diagnostic devices
into the
peripheral
vasculature of
the lower extremities |
| Operation
Principle | Operated manually or
by a manual
process; | Same | Same |
| Design /
Construction | Sheath, Dilator,
Hemostatic Valve with
side tube and three-way
stopcock | Same | Guiding Catheter,
Inner Guide |
Table 12.1: Summary of Substantial Equivalence
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Image /page/6/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The font is sans-serif and bolded.
| Materials | Sheath Assembly | Sheath Assembly | Guiding Catheter: |
|---|---|---|---|
| Tubing: | Tubing: | Outer layer: | |
| Inner Layer: PTFE | Inner Layer: PTFE | Polyamide elastomer | |
| (Nylon) | |||
| Middle Coil Layer: | Middle Coil Layer: | Middle Braid Layer: | |
| Stainless Steel | Stainless Steel | Stainless steel | |
| Outer Layer: Nylon | Outer Layer: Nylon | Inner layer: | |
| Polytetrafluoroethylene | |||
| Radiopaque Tip: Nylon | |||
| with Tungsten | Tip: Nylon | ||
| Radiopaque Band: | |||
| Gold | Radiopaque Tip: | ||
| Polyamide Elastomer | |||
| (Nylon) with Tungsten | |||
| Hydrophilic Coating: | |||
| Polyvinylpyrrolidone- | |||
| based coating | Hydrophilic Coating: | ||
| Polyvinylpyrrolidone- | |||
| based coating | Hydrophilic Coating: | ||
| Dimethyl acrylic amide |
- glycidyl methacrylate |
| | Hub: Nylon | Hub: Nylon | Hub: Polyamide 12 |
| | Anti-kink protector:
Nylon | | Anti-kink protector:
Polyester Elastomer |
| | Dilator Assembly
Tubing: Polypropylene
Hub: Polypropylene/
/Thermoplastic
Elastomer Blend
Coating: Silicone
Caulking Pin: Stainless
steel | Dilator Assembly
Same | Inner Guide:
Shaft: Polyester
Elastomer with
Tungsten
Hub: Polyamide
Lock Adaptor:
polycarbonate |
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Image /page/7/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and bold.
| Cross Cut Valve | Cross Cut Valve | None | |
|---|---|---|---|
| Valve Assembly: | Valve Assembly: | ||
| Housing: | Same | ||
| Polypropylene | |||
| Cap: Polypropylene | |||
| Luer Lock Collar: | |||
| Polycarbonate | |||
| Valve: Silicone Rubber | |||
| Elastomer | |||
| Sidetube: | |||
| polybutadiene | |||
| Silicone: Non-reactive | |||
| silicone oil 1000cst | |||
| Side Tube Assembly: | Side Tube Assembly: | ||
| Body: Polybutadiene | Same | ||
| 3Way (3WSC) | 3Way (3WSC) | ||
| Stopcock Assembly: | Stopcock Assembly: | ||
| Body: Polycarbonate | Same | ||
| Locking | |||
| Pin: Polyethylene | |||
| Cap: Polyethylene and | |||
| Colorant | |||
| Handle: Polyethylene | |||
| and Colorant | Tuohy-Borst Valve | ||
| Lock Adaptor: | Similar material as | ||
| Polycarbonate | Cross Cut Valve | ||
| Package | Unit Pouch | Unit Pouch | Unit Pouch |
| Shelf Box | Shelf Box | Shelf Box | |
| Shipping Carton | Shipping Carton | Shipping Carton |
8
Image /page/8/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red arc above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.
| Specifications | Sheath Size: 6 Fr. | Sheath Size: 6-7 Fr. | Catheter Size: 7Fr |
|---|---|---|---|
| Sheath ID/OD | |||
| (nominal): | Sheath ID/OD | ||
| (nominal): | I.D.: 2.20 mm (0.087") | ||
| 6Fr.: 0.087"/0.100" | |||
| (2.2mm /2.5mm) | 6Fr.: 0.087"/0.111" | ||
| 7Fr.: 0.100"/0.122" | O.D.: 2.37 mm | ||
| (0.093") | |||
| Sheath Length: | |||
| 119cm, 149cm | Sheath Length: | ||
| 80-110cm | Effective lengths: | ||
| 120cm, 150cm | |||
| Hydrophilic Coating: | |||
| full effective length | Hydrophilic Coating: | ||
| Distal 15cm | |||
| Distal Shape: Straight | Distal Shapes: Straight, | ||
| Angled (40 degrees) | |||
| Dilator ID/OD | |||
| (nominal): | Dilator ID/OD | ||
| (nominal): | Inner Guide | ||
| Accepts guide wire | |||
| diameter: 0.035" | |||
| 0.039"/0.086" | 6Fr.: 0.045”/0.084" | ||
| 7Fr.: 0.045”/0.097" | |||
| Dilator Extended | |||
| Length: 5cm | Dilator Extended | ||
| Length: 5cm | |||
| Sterilization | Ethylene Oxide | ||
| (validated in | |||
| accordance with ANSI | |||
| / AAMI / ISO 11135-1 | |||
| to achieve SAL 10-6) | Same | Same | |
| Shelf life | 30 months | Same | 36 months |
| Disposable | |||
| Single Use | Yes | Same | Same |
H. NON-CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure that the R2P™ Destination Slender™ Guiding Sheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
The following table provides a list of the performance tests that were performed on the proposed R2P™ Destination Slender™ Guiding Sheath.
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Image /page/9/Picture/1 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.
| Table 5.4: Summary of Performance Testing | ||
|---|---|---|
| Test Item | Reference | Component |
| (Sheath, | ||
| Dilator, CCV | ||
| Assembly) | ||
| Three-Point Bend | In-house standard | Sheath |
| Hub Joint Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Tubing Tensile Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Tip Tensile Strength | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Ovalization | In-house standard | Sheath |
| Lubricity and Durability | In-house standard | Sheath |
| Uncoated Length | In-house standard | Sheath |
| Corrosion Resistance | ISO 11070:2014 | Sheath, Dilator |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Gauging | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-1:1986 | ||
| Liquid Leakage of Luer | ||
| under Pressure | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Air Leakage | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Separation Force | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Unscrewing Torque | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | ||
| Ease of Assembly | ISO 11070:2014 | Sheath |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| Test Item | Reference | Component |
| (Sheath, | ||
| Dilator, CCV | ||
| Assembly) | ||
| ISO 594-2:1998 | ||
| Resistance to Overriding | ISO 11070:2014 | |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | Sheath | |
| Stress Cracking | ISO 594-2:1998 | |
| ISO 11070:2014 | ||
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | ||
| ISO 594-2:1998 | Sheath | |
| Simulated Use and | ||
| Particulate* | FDA Guidance Doc 1608 | Sheath, Dilator, |
| CCV | ||
| Radiodetectability | ISO 11070:2014 | |
| ISO 10555-1:2013 | Sheath, Dilator | |
| Visual Inspection of | ||
| External Surface | ISO 11070:2014 | |
| ISO 10555-1:2009 | ||
| ISO 10555-1:2013 | Sheath, Dilator | |
| Sheath Tip Inner Diameter | In-house standard | Sheath |
| Sheath Hub Inner Diameter | In-house standard | Sheath |
| Dilator Bump Inner | ||
| Diameter | In-house standard | Dilator |
| Outer Diameter | ||
| Measurement | In-house standard | Sheath, Dilator |
| Effective Length | In-house standard | Sheath, Dilator |
| Coating Integrity | FDA Guidance Doc 1608 | Sheath |
| Liquid Leakage of the | ||
| Sheath | ISO 11070:2014 | Sheath |
| Liquid Leakage Through | ||
| Hemostasis Valve | ISO 11070:2014 | CCV |
| Torque Strength | FDA Guidance Doc 1608 | Sheath |
| Dilator Tip Inner Diameter | In-house standard | Dilator |
| Dilator Tip Penetration | In-house standard | Dilator |
Table 5.4: Summary of Performance Testing
10
The R2P™ Destination Slender™ Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed R2PTM Destination Slender™ Guiding Sheath is substantially equivalent.
11
Image /page/11/Picture/1 description: The image shows the logo for Terumo. The logo consists of a red curved line above the word "TERUMO" in green. The word "TERUMO" is in a bold, sans-serif font.
Biocompatibility
Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process."
The R2PTM Destination Slender™ Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (