(55 days)
K171491 R2P™ Destination Slender™ Guiding Sheath
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guiding sheath, with no mention of AI or ML capabilities.
No.
The device is a guiding sheath used for the introduction of interventional and diagnostic devices, not for therapeutic treatment itself.
No
The device is a guiding sheath used for introducing other devices, including diagnostic ones, into the vasculature. However, it is not itself a diagnostic device as it does not perform diagnostic functions.
No
The device description clearly outlines a physical, hardware-based medical device (guiding sheath, dilator, hemostatic valve) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introduction of interventional and diagnostic devices into the human vasculature through an access site." This describes a device used in vivo (within the body) for accessing blood vessels and delivering other medical devices.
- Device Description: The description details a physical device (sheath, dilator, valve) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically reagents, instruments, or systems used for testing these types of samples.
Therefore, the R2P™ Destination Slender™ Guiding Sheath is a medical device used for vascular access and delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The R2P™ 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 75cm, 85cm, 95cm, 105cm, 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
human vasculature, radial artery
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.
Test Items: Ovalization, Simulated Use and Particulate, Coating Integrity, Torque Strength.
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 R2P™ Destination Slender™ Guiding Sheath demonstrates the substantial equivalence to the predicate device.
Biocompatibility classification 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 R2P™ Destination Slender™ Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours). The subject device is covered by the previously completed biocompatibility and chemistry testing done on the 149cm guiding sheath. Therefore, the subject devices (75cm, 85cm, 95cm, 105cm, 149cm, and 119cm) are considered to be biocompatible for the intended use and no additional biocompatibility testing is required.
Sterility of the predicate devices (119cm and 149cm) assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The sterilization process was previously validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6. The subject devices (75cm, 85cm, 95cm, 105cm, 119cm, and 149cm) are covered by the previously completed sterilization validation and no additional sterilization validation is required.
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.
K171491 R2P™ Destination Slender™ Guiding Sheath
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 6, 2020
Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, Maryland 21921
Re: K193125
Trade/Device Name: R2P Destination Slender Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 11, 2019 Received: November 12, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name R2PTM Destination Slender™ Guiding Sheath
Indications for Use (Describe)
R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
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 265 Davidson Avenue, Suite 320 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
January 3, 2020 Date prepared:
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | R2P TM Destination SlenderTM Guiding Sheath | Device
Characteristic | Predicate Device:
R2PTM Destination Slender™
Guiding Sheath (K171491) | Proposed Device:
R2PTM Destination Slender™
Guiding Sheath |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Guiding Sheath | Manufacturer | Terumo Medical Corporation | Same |
| Classification Name: | Catheter Introducer | 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. | R2PTM Destination Slender™
Guiding Sheath is indicated for the
introduction of interventional and
diagnostic devices into the human
vasculature through an access site,
including but not limited to the
radial artery. |
| Classification Panel: | Cardiovascular | Operation
Principle | Operated manually or by a manual
process | Same |
| Regulation: | 21 CFR 870.1340 | Design /
Construction | Sheath, Dilator, Hemostatic Valve
with side tube and three-way
stopcock | Same |
| Product Code: | DYB | Materials | Sheath Assembly
Tubing:
Inner Layer: PTFE
Middle Coil Layer: Stainless Steel
Outer Layer: Nylon
Radiopaque Tip: Nylon with
Tungsten
Hydrophilic Coating:
Polyvinylpyrrolidone- based
coating
Hub: Nylon
Anti-kink protector: Nylon | Sheath Assembly
Same |
| Classification: | Class II | | Dilator Assembly
Tubing: Polypropylene
Hub: Polypropylene/
/Thermoplastic Elastomer Blend
Coating: Silicone
Caulking Pin: Stainless steel | Dilator Assembly
Same |
| | Cross Cut Valve (CCV)
Valve Assembly:
Housing: Polypropylene
Cap: Polypropylene
Luer Lock Collar: Polycarbonate
Valve: Silicone Rubber Elastomer
Sidetube: polybutadiene
Silicone: Non-reactive silicone oil
1000cst | Cross Cut Valve (CCV)
Valve Assembly:
Same | | |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed is:
- Predicate Device: K171491 R2P™ Destination Slender™ Guiding Sheath, ● manufactured by Terumo Medical Corporation, USA
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the R2PTM 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 R2P™ 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 75cm, 85cm, 95cm, 105cm, 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 for the introduction of interventional and diagnostic devices into the human 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.
A comparison of the technological characteristics is summarized in the table below.
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| | Side Tube Assembly: Body:
Polybutadiene | Side Tube Assembly:
Same |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| | 3Way (3WSC) Stopcock
Assembly:
Body: Polycarbonate
Locking Pin: Polyethylene
Cap: Polyethylene and Colorant
Handle: Polyethylene and
Colorant | 3Way (3WSC) Stopcock
Assembly: Same |
| Package | Unit Pouch
Shelf Box
Shipping Carton | Same |
| Specifications | Sheath Size: 6 Fr.
Sheath ID/OD (nominal):
6Fr.: 0.087"/0.100" (2.2mm
/2.5mm) | Sheath Size: Same
Sheath ID/OD (nominal):
Same |
| | Sheath Length:
119cm, 149cm | Sheath Length:
75cm, 85cm, 95cm, 105cm,
119cm, and 149cm |
| | Hydrophilic Coating: full effective
length | Hydrophilic Coating: Same |
| | Distal Shape: Straight | Distal Shape: Same |
| | Dilator ID/OD (nominal):
0.039"/0.086" | Dilator ID/OD (nominal):
Same |
| | Dilator Extended Length: 5cm | Dilator Extended Length: Same |
| Sterilization | Ethylene Oxide (validated in
accordance with ANSI / AAMI /
ISO 11135-1 to achieve SAL 10-6) | Same |
| Shelf life | 30 months | Same |
| Disposable Single
Use | Yes | Same |
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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 R2PTM Destination Slender™ Guiding Sheath.
| Test Item | Reference | Component
(Sheath,
Dilator, CCV
Assembly) |
|----------------------------------|-----------------------|----------------------------------------------------|
| Ovalization | In-house standard | Sheath |
| Simulated Use and
Particulate | FDA Guidance Doc 1608 | Sheath, Dilator,
CCV |
| Coating Integrity | FDA Guidance Doc 1608 | Sheath |
| Torque Strength | FDA Guidance Doc 1608 | Sheath |
Table 5.2: Summary of Performance Testing
The R2PTM 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 demonstrates the substantial equivalence to the predicate device.
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 (≤24 hours).
The predicate guiding sheaths (119cm and 149cm) have fulfilled all testing required per ISO 10993-1 and FDA Guidance document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
No changes in the materials, design, manufacturing processes, or packaging materials were made from the predicate device. The new additional four (4) shorter guiding sheaths (75cm, 85cm, 95cm, and 105cm) have the same contact nature and duration as the existing predicate guiding sheaths (119cm and 149cm). The predicate guiding sheaths (119cm and 149cm) have higher surface areas, which is the worstcase when compared to the new additional guiding sheaths (75cm, 85cm, and 105cm).
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The subject device is covered by the previously completed biocompatibility and chemistry testing done on the 149cm guiding sheath. Therefore, the subject devices (75cm, 85cm, 95cm, 105cm, 149cm, and 119cm) are considered to be biocompatible for the intended use and no additional biocompatibility testing is required.
Sterilization
The sterility of the predicate devices (119cm and 149cm) are assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was previously validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
The predicate devices (119cm and 149cm) are limited exposure devices. After 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.
The subject devices (75cm. 85cm. 95cm. 105cm. 119cm. and 149cm) have the same configuration, materials of the construct, and manufacturing process as the predicate products: the only change is the length of the device. The manufacturing process will occur in the same manufacturing environment and use the same manufacturing process and materials. The length change to 75cm. 85cm, 95cm, and 105cm, will not affect the efficacy of the current sterilization process and will not create a greater challenge to the cycle than the existing validated process challenge device. Therefore, the subject devices (75cm, 85cm, 95cm, 119cm, and 149cm) are covered by the previously completed sterilization validation and no additional sterilization validation is required.
CLINICAL TESTS (807.92(b)(2)) I.
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the R2PTM Destination Slender™ Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device:
- Predicate Device: K171491 R2PTM Destination Slender™ Guiding Sheath, . manufactured by Terumo Medical Corporation, USA