(58 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a sheath introducer, with no mention of AI or ML capabilities.
No
The device is an introducer sheath, which facilitates the introduction of other devices into the body, but it does not directly perform a therapeutic action itself. Its intended use states "facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures." This indicates it's an accessory to procedures, not a therapeutic device on its own.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "a variety of diagnostic and therapeutic procedures," indicating its involvement in diagnostic processes.
No
The device description clearly outlines a physical, coil-reinforced catheter with a valved hub, extension tubing, and a three-way stopcock. It also mentions a dilator and guidewire accessory, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "providing access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a catheter designed to be inserted into blood vessels. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Thinline Sheath Introducer is a medical device used for vascular access, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiovascular
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)
Design verification and validation were performed to ensure that the Thinline Introducer Sheath meets its performance specifications and demonstrates substantial equivalence to the predicate device. A list of the performance testing conducted is presented below in Table 6.2. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All pre-determined acceptance criteria were met.
In some cases, verification test data were leveraged from data that had been generated from testing done on previously cleared devices.
Performance Bench Tests Performed on the Thinline Introducer Sheath:
Design Verification Testing:
- Tensile Strength: Pass. Testing was completed per ISO 10555-1, Section 4.6 and Annex B.
- PTFE delamination: Pass. PTFE liner was visually inspected to ensure that delamination of the liner was not present.
- Torque Strength: Pass. The device must withstand one turn of the hub.
- Catheter Burst: Pass. Testing was completed per ISO10555-1, Section 4.10 and Annex F.
- Visual Inspection: Pass. Samples were visually inspected under 2.5X magnification to ensure acceptance criteria were met.
- Particulates: Pass. Testing was completed per USP [788]. Testing was also performed in comparison to the predicate.
- Liquid Leak Test (sheath and hemostasis valve): Pass. Testing was conducted per ISO 10555-1, Section 4.7 and Annex C.
- Air Leak Test: Pass. Testing was conducted per ISO 10555-1 section 4.7.2 and Annex D.
- Dimensional Verification: Pass. The catheter and introducer must meet specifications.
- Coating Length: Pass. The sheath length with hydrophilic coating must meet specifications.
- Chemical Compatibility: Pass. The device shall withstand exposure to saline, dextrose, heparin, and contrast.
- Tip Flexibility/Stiffness: Pass. Units will be held at 5 mm, 10 mm, and 20 mm from the distal tip, and a tensile test stand will be used to record the force required to displace the tip by 1 mm. Testing conducted per FDA Guidance Document #1600, Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling.
- Hub Compatibility: Pass. Catheter luers shall be tested per ISO 594-1:1986 and ISO 594-2:1998.
- Kink Resistance: Pass. After conditioning, two points on each test sample were wrapped around progressively smaller diameter pegs and/or mandrels until a kink was observed.
- Packaging - Pouch Leak Test: Pass. Testing was conducted per ASTM F-1929.
- Packaging - Pouch Peel Test: Pass. Testing was conducted per ASTM F88/F88M.
- Packaging - Visual Inspection: Pass. Packaging was visually inspected to determine if any perforations, nicks, cuts, or punctures on the pouch were present. All pouch seals were also visually inspected to verify that seals were not damaged or peeled, and that all seals were intact.
- Label Legibility: Pass. Labeling will be inspected visually to ensure text remains legible after transportation and environmental conditioning.
- Packaging - Seal Width: Pass. The seals will meet the specified width.
Design Validation Testing:
- In-vitro Simulated Use Study – Benchtop: Pass. The Thinline Sheath Introducer was prepared per the IFU. A simulated interventional procedure was performed by physicians in order to verify the product's performance.
- In-vitro Simulated Use Study - Useability: Pass. Participating physicians were asked to rate various aspects of the Thinline Sheath Introducer including performance and IFU.
Biocompatibility testing: Biocompatibility of the Thinline Introducer Sheath was leveraged from the reference device (K171672) based on the similarities in design, materials, suppliers, and processing. The following biocompatibility endpoints were leveraged to support the substantial equivalence of the subject device:
- Cytotoxicity: MEM elution, 48 hr. inc., triplicate L929, 24 hr. ext. (nonimplant)
- Sensitization: Magnusson-Kligman Method, 2 extracts
- Irritation: Intracutaneous Toxicity (ISO), 2 extracts
- Material mediated pyrogenicity: Material Mediated Pyrogen
- Acute Systemic Toxicity: Systemic Injection (ISO), 2 extracts
- Hemocompatibility: Hemolysis, ASTM Method, indirect (human blood); Hemolysis, ASTM Method, direct contact (human blood); Complement Activation, SC5b-9; Dog Thrombogenicity
Sterilization Validation: A confirmatory sterilization study was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide sterilization cycle. The device passed all sterility, EO residual, LAL, and bioburden testing.
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.
Merit Prelude Ideal 9F Hydrophilic Sheath Introducer #K212152
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.
Zenith (065 and 074) #K171672
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). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The text reads "U.S. Food & Drug Administration".
September 27, 2023
Inneuroco Inc. Garry Koroshec Staff Design Quality Engineer / Regulatory Affairs 19700 Stirling Road, Suite 1 Pembroke Pines, Florida 33332
Re: K232260
Trade/Device Name: Thinline Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 28, 2023 Received: July 31, 2023
Dear Garry Koroshec:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation reguires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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,
Finn E.
Donaldson -S
Digitally signed by Finn E.
Donaldson -S
Date: 2013.09.27 14:15:45
-04'00'
For Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality
2
Enclosure
3
Indications for Use
510(k) Number (if known) K232260
Device Name Thinline Sheath Introducer
Indications for Use (Describe)
The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
| 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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4
510(k) Summary
| Date Summary Prepared | September 27, 2023 |
|---|---|
| Submitter | InNeuroCo Inc. |
| 19700 Stirling Road, Suite 1 | |
| Pembroke Pines, FL 33332 | |
| Primary Submission Contact | Garry Koroshec |
| Staff Design Quality Engineer / Regulatory Affairs | |
| InNeuroCo Inc. | |
| 19700 Stirling Road, Suite 1 | |
| Pembroke Pines, FL 33332 | |
| Telephone: 1-954-254-5003 | |
| Facsimile: 1-954-742-5989 | |
| E-Mail: garry@inneuroco.com | |
| Secondary Submission Contacts | Marianne Grunwaldt |
| Senior Director of Regulatory Affairs and Quality Assurance | |
| InNeuroCo Inc. | |
| 19700 Stirling Road, Suite 1 | |
| Pembroke Pines, FL 33332 | |
| Telephone: 1-954-703-5271 | |
| Facsimile: 1-954-742-5989 | |
| E-Mail: marianne@inneuroco.com | |
| Ming Cheng Chew | |
| Regulatory Consultant | |
| RQM+ | |
| 8401 73rd Avenue North, Suite 63 | |
| Brooklyn Park, MN 55428 | |
| Telephone: 763-232-3701 | |
| E-Mail: mchew@rqmplus.com | |
| Trade name | Thinline Sheath Introducer |
| Regulation Number | 21 CFR 870.1340 |
| Device Common or Classification | |
| Name | Catheter Introducer |
| Product Class | Class II |
| Product Panel | Cardiovascular |
| Product Code | DYB |
| Predicate Device | Merit Prelude Ideal 9F Hydrophilic Sheath Introducer |
| #K212152 | |
| Reference Device | Zenith (065 and 074) |
| #K171672 |
5
6.1 Device Description
The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
6.2 Indications for Use
The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
6.3 Technological Characteristics and Basis for Substantial Equivalence
Table 6.1 Technological Comparison between the Thinline Introducer Sheath and Prelude Ideal 9F Hydrophilic Sheath Introducer (K212152)
| Parameter | Predicate Device
Prelude Ideal 9F Hydrophilic Sheath
Introducer (K212152) | Subject Device
Thinline Introducer Sheath
(K232260) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The 9F Prelude Ideal Hydrophilic Sheath
Introducer is intended to provide access and
facilitate the percutaneous introduction of
various devices into veins and/or arteries
while maintaining hemostasis for a variety of
diagnostic and therapeutic procedures. | The Thinline Sheath Introducer is intended to
provide access and facilitate the
percutaneous introduction of various devices
into veins and/or arteries while maintaining
hemostasis for a variety of diagnostic and
therapeutic procedures. |
| Anatomical
Location | Cardiovascular | Cardiovascular |
| Product Code | DYB | DYB |
| Classification | Class II | Class II |
| Regulation
Number | 870.1340 | 870.1340 |
| Coating | Yes | Yes |
| Internal
construction | Single Lumen | Single Lumen |
| Working Length | 11 cm, 23 cm | 11 cm, 23 cm |
| Max Outer
Diameter | 0.138 inches | 0.142 inches |
| Shaft Inner
diameter | 0.126 inches | 0.126 inches |
| Accessories
supplied | Dilator
Guidewire
Metal Access Needle
Guide Wire Insertion Device | Dilator
Guidewire |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Number of Uses | Single Use | Single Use |
6
6.4 Performance Data
Design verification and validation were performed to ensure that the Thinline Introducer Sheath meets its performance specifications and demonstrates substantial equivalence to the predicate device. A list of the performance testing conducted is presented below in Table 6.2. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All pre-determined acceptance criteria were met.
In some cases, verification test data were leveraged from data that had been generated from testing done on previously cleared devices.
| Test performed | Test Summary | Results |
|---|---|---|
| Design Verification Testing | ||
| Tensile Strength | Testing was completed per ISO 10555-1, Section 4.6 and | |
| Annex B. | Pass | |
| PTFE delamination | PTFE liner was visually inspected to ensure that | |
| delamination of the liner was not present. | Pass | |
| Torque Strength | The device must withstand one turn of the hub | Pass |
| Catheter Burst | Testing was completed per ISO10555-1, Section 4.10 | |
| and Annex F. | Pass | |
| Visual Inspection | Samples were visually inspected under 2.5X magnification | |
| to ensure acceptance criteria were met. | Pass | |
| Particulates | Testing was completed per USP . Testing was also | |
| performed in comparison to the predicate. | Pass | |
| Liquid Leak Test (sheath and | ||
| hemostasis valve) | Testing was conducted per ISO 10555-1, Section 4.7 and | |
| Annex C. | Pass | |
| Air Leak Test | Testing was conducted per ISO 10555-1 section 4.7.2 and | |
| Annex D. | Pass | |
| Dimensional Verification | The catheter and introducer must meet specifications | Pass |
| Coating Length | The sheath length with hydrophilic coating must meet | |
| specifications | Pass | |
| Chemical Compatibility | The device shall withstand exposure to saline, dextrose, | |
| heparin, and contrast | Pass | |
| Tip Flexibility/Stiffness | Units will be held at 5 mm, 10 mm, and 20 mm from the | |
| distal tip, and a tensile test stand will be used to record the | ||
| force required to displace the tip by 1 mm. Testing | ||
| conducted per FDA Guidance Document #1600, | ||
| Coronary, Peripheral, and Neurovascular Guidewires - | ||
| Performance Tests and Recommended Labeling. | Pass | |
| Hub Compatibility | Catheter luers shall be tested per ISO 594-1:1986 and | |
| ISO 594-2:1998 | Pass | |
| Kink Resistance | After conditioning, two points on each test sample were | |
| wrapped around progressively smaller diameter pegs | ||
| and/or mandrels until a kink was observed. | Pass | |
| Packaging - Pouch Leak Test | Testing was conducted per ASTM F-1929. | Pass |
| Packaging - Pouch Peel Test | Testing was conducted per ASTM F88/F88M. | Pass |
| Packaging - Visual Inspection | Packaging was visually inspected to determine if any | |
| perforations, nicks, cuts, or punctures on the pouch were | ||
| present. All pouch seals were also visually inspected to | ||
| verify that seals were not damaged or peeled, and that all | ||
| seals were intact. | Pass | |
| Label Legibility | Labeling will be inspected visually to ensure text remains | |
| legible after transportation and environmental | ||
| conditioning. | Pass | |
| Packaging - Seal Width | The seals will meet the specified width | Pass |
| Design Validation Testing | ||
| In-vitro Simulated Use Study – | ||
| Benchtop | The Thinline Sheath Introducer was prepared per the IFU. | |
| A simulated interventional procedure was performed by | ||
| physicians in order to verify the product's performance. | Pass | |
| Test performed | Test Summary | Results |
| In-vitro Simulated Use Study - | ||
| Useability | Participating physicians were asked to rate various | |
| aspects of the Thinline Sheath Introducer including | ||
| performance and IFU | Pass |
Table 6.2 – Performance Bench Tests Performed on the Thinline Introducer Sheath
7
8
6.5 Biocompatibility testing
Biocompatibility of the Thinline Introducer Sheath was leveraged from the reference device (K171672) based on the similarities in design, materials, suppliers, and processing. The following biocompatibility endpoints were leveraged to support the substantial equivalence of the subject device:
| Biological Effect | Test |
|---|---|
| Cytotoxicity | MEM elution, 48 hr. inc., triplicate L929, 24 hr. ext. (nonimplant) |
| Sensitization | Magnusson-Kligman Method, 2 extracts |
| Irritation | Intracutaneous Toxicity (ISO), 2 extracts |
| Material mediated pyrogenicity | Material Mediated Pyrogen |
| Acute Systemic Toxicity | Systemic Injection (ISO), 2 extracts |
| Hemocompatibility | Hemolysis, ASTM Method, indirect (human blood) |
| Hemolysis, ASTM Method, direct contact (human blood) | |
| Complement Activation, SC5b-9 | |
| Dog Thrombogenicity |
Table 6.3 Summary of Biocompatibility Testing Leveraged from the Reference Device (K171672)
6.6 Sterilization Validation
A confirmatory sterilization study was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide sterilization cycle. The device passed all sterility, EO residual, LAL, and bioburden testing.
6.7 Conclusion
Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the Thinline Introducer Sheath, is substantially equivalent to the predicate Merit Prelude Ideal 9F Hydrophilic Sheath Introducer #K212152.