(269 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML algorithms.
No.
The device is described as a steerable sheath and dilator used for introducing cardiovascular catheters to the heart, which are tools for accessing anatomical sites rather than directly treating a condition.
No
The device is described as a steerable sheath and dilator intended for introducing various cardiovascular catheters to the heart for catheterization and angiography, which are procedural rather than diagnostic functions. There is no mention of the device itself providing diagnostic information.
No
The device description explicitly details physical components (sheath, dilator, guidewire) made of materials like stainless steel and PTFE, and the performance studies focus on physical properties and functionality (torque control, flexibility, radiopacity, tensile strength, etc.). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a steerable sheath and dilator used to introduce cardiovascular catheters into the heart. This is an invasive procedure performed in vivo (within the living body), not on a sample in vitro (outside the living body).
- Intended Use: The intended use is to facilitate the introduction of other devices into the heart, not to perform a diagnostic test on a biological sample.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
PNE
Device Description
The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.
The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainless-steel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.
The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainless-steel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, including the left side of the heart through the interatrial septum.
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)
Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation ●
- Functional Testing ●
- Visual Inspection
- Dimensional Inspection ●
- Tip Deflection ●
- Tip Buckling ●
- Valve/Joint leak ●
- Radiopacity ●
- Simulated Use ●
- Torque Testing ●
- Tensile Testing ●
- Corrosion Testing ●
- Packaging Validation ●
Innovative Health concludes that the testing evaluated substantial equivalence to the predicate devices described herein.
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.
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.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 4, 2024
Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K232037
Trade/Device Name: Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Reprocessed Catheter Introducer Regulatory Class: Class II Product Code: PNE Dated: February 20, 2024 Received: February 20, 2024
Dear Amanda Babcock:
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 (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/cdrb/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.
1
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).
Your device is also subject to, among other requirements, the Quality System (OS) 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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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 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-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
Julie B. Mackel -S
For
Katherine Trivedi
2
Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
The Reprocessed Device Models in scope of K232037 are as follows:
| Product
Description | Item Number | Sheath
French
Size | Sheath
Length | Sheath
Curve | Bidirectional
Curve Angle | Dilator
French
Size | Dilator
Length | Dilator
Curve |
|--------------------------------------------------|--------------------|--------------------------|------------------|-----------------|------------------------------|---------------------------|-------------------|------------------|
| Reprocessed
VersaCross
Steerable
Sheath | VST85-35-BD-71S-D0 | 8.5F | 72 cm | S | 90° CCW/
180°CW | 8.5F | 95 cm | D0 |
| | VST85-35-BD-71S-D1 | | | S | | | | D1 |
| | VST85-35-BD-71M-D0 | | | M | | | | D0 |
| | VST85-35-BD-71M-D1 | | | M | | | | D1 |
| | VST85-35-BD-71L-D0 | | | L | | | | D0 |
| | VST85-35-BD-71L-D1 | | | L | | | | D1 |
| Product
Description | Item Number | Sheath
French
Size | Sheath
Length | Sheath
Curve | Bidirectional
Curve Angle | Dilator
French
Size | Dilator
Length | Dilator
Curve |
|-----------------------------------------------------------|-----------------|--------------------------|------------------|-----------------|------------------------------|---------------------------|-------------------|------------------|
| Reprocessed
SureFlex
Steerable
Guiding
Sheath | TSK85-32-BD-71S | 8.5F | 71 cm | S | 90° CCW/
180°CW | 8.5F | 94 cm | N/A |
| | TSK85-32-BD-71M | | | M | | | | N/A |
| | TSK85-32-BD-71L | | | L | | | | N/A |
4
Indications for Use
510(k) Number (if known)
Device Name
Reprocessed VersaCross Steerable Sheath and Reprocessed SureFlex Steerable Guiding Sheath
Indications for Use (Describe)
The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
| 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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5
510(k) SUMMARY
As required by 21 CFR 807.92
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7706 (fax) ababcock@innovative-health.com
Date prepared:
July 7, 2023
Device Information:
| Trade/Proprietary Name: | Reprocessed VersaCross Steerable Sheath and SureFlex |
|---|---|
| Steerable Guiding Sheath | |
| Common Name: | Steerable/Guiding Sheath |
| Classification Name: | Reprocessed Catheter Introducer |
| Classification Number: | Class II, 21 CFR 870.1340 |
| Product Code: | PNE |
Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K190688 | VersaCross Steerable Sheath | Baylis Medical |
| VersaCross Transseptal Dilator | Company, Inc. |
Additional Predicate Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K122926 | SureFlex Steerable Guiding Sheath Kit | Baylis Medical |
| Company Inc. |
Reference Device:
| 510(k) Number | 510(k) Device | Manufacturer |
|---|---|---|
| K170311 | Reprocessed Agilis NxT Steerable | |
| Introducer | Innovative Health, LLC. |
6
Device Description: Reprocessed VersaCross Steerable Sheath
The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.
The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
Reprocessed Sureflex Steerable Sheath
The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.
The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.
The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.
Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.
Indications for Use:
The Reprocessed VersaCross Steerable Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
The Reprocessed SureFlex Steerable Guiding Sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
7
The item numbers in scope of this submission are as follows:
| Product
Description | Item Number | Sheath
French
Size | Sheath
Length | Sheath
Curve | Bidirectional
Curve Angle | Dilator
French
Size | Dilator
Length | Dilator
Curve |
|-----------------------------------------------------------|--------------------|--------------------------|------------------|-----------------|------------------------------|---------------------------|-------------------|------------------|
| Reprocessed
VersaCross
Steerable
Sheath | VST85-35-BD-71S-D0 | 8.5F | 72 cm | S | 90° CCW/
180°CW | 8.5F | 95 cm | D0 |
| | VST85-35-BD-71S-D1 | | | S | | | | D1 |
| | VST85-35-BD-71M-D0 | | | M | | | | D0 |
| | VST85-35-BD-71M-D1 | | | M | | | | D1 |
| | VST85-35-BD-71L-D0 | | | L | | | | D0 |
| | VST85-35-BD-71L-D1 | | | L | | | | D1 |
| Reprocessed
SureFlex
Steerable
Guiding
Sheath | TSK85-32-BD-71S | 8.5F | 71 cm | S | 90° CCW/
180°CW | 8.5F | 94 cm | N/A |
| | TSK85-32-BD-71M | | | M | | | | N/A |
| | TSK85-32-BD-71L | | | L | | | | N/A |
Table 1: Device Scope
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed devices are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition. Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected, and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation ●
- Functional Testing ●
- Visual Inspection
- Dimensional Inspection ●
- Tip Deflection ●
- Tip Buckling ●
- Valve/Joint leak ●
- Radiopacity ●
- Simulated Use ●
- Torque Testing ●
- Tensile Testing ●
- Corrosion Testing ●
- Packaging Validation ●
The Reprocessed Steerable Sheaths are reprocessed no more than one (1) time. Each device is marked, serialized, and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
8
Conclusion:
Innovative Health concludes that the testing evaluated substantial equivalence to the predicate devices described herein.