(210 days)
No
The device description and performance studies focus on the mechanical, physical, and biocompatibility properties of a simple medical device (a stylet) and its accessory (a flushable hub). There is no mention of software, algorithms, data processing, or any characteristics typically associated with AI/ML.
No.
The device is intended to stiffen a catheter to aid in its placement, which is an ancillary function to the catheter itself and does not provide direct therapeutic benefit to the patient. It's a tool for a medical procedure rather than a therapeutic instrument.
No
Explanation: The Arrow Stiffening Stylet is intended to stiffen a catheter to aid in its placement. Its function is purely mechanical, and it does not gather or interpret any information about the patient's condition or disease for diagnostic purposes.
No
The device description clearly outlines a physical medical device made of nitinol wire with a PTFE coating, intended for insertion into a catheter. The performance studies also detail physical and mechanical testing, further indicating it is a hardware device.
Based on the provided information, the Arrow Stiffening Stylet is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to stiffen a catheter for placement within the peripheral vasculature. This is a direct intervention on the patient's body for a medical procedure.
- Device Description: The description details a physical device (stylet) used to manipulate another medical device (catheter) within 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.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for procedural assistance.
N/A
Intended Use / Indications for Use
The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.
Product codes (comma separated list FDA assigned to the subject device)
DRB
Device Description
The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body.
The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance Data:
Mechanical/Physical testing in accordance with ISO 11070, Guidance Documents, and Arrow International Internal Requirements:
- Surface: Extraneous Matter and Defects
- Corrosion Resistance
- Radio-detectability
- Guide wire Fracture
- Guide wire Flexure
- Guide wire Tensile
- Retainer Leak (Flushable Hub Interface)
- Retainer Grip (Flushable Hub Interface)
- Coating Integrity
- Particulate
- Torque Test
- Stiffness
- Removal Force from Catheter
Human Factors/Usability Testing
Biocompatibility testing in accordance with ISO 10993-1: - Cytotoxicity (MEM Elution)
- Sensitization Kligman Maximization Test (polar and non-polar extracts)
- Intracutaneous Injection (polar and non-polar extracts)
- Acute Systemic Toxicity (polar and non-polar extracts)
- Materials Mediated Pyrogenicity
- Hemolysis (direct and indirect contact)
The Arrow Stiffening Stylet will be packaged as a convenience kit component with Arrow Peripherally Inserted Central Catheter (PICC) products. There are no changes to the packaging introduced by this submission.
No human clinical data was required to support substantial equivalence.
Key results: The testing conducted that supports substantial equivalence of the subject Arrow Stiffening Stylet is listed. All acceptance criteria were passed, verifying that the proposed Arrow Stiffening Stylet meets its design, physical integrity, functional, and safety requirements and that any dimensional or material differences between it and the predicate stylet do not raise new issues of safety and effectiveness.
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
§ 870.1380 Catheter stylet.
(a)
Identification. A catheter stylet is a wire that is run through a catheter or cannula to render it stiff.(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: the Department of Health & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
August 31, 2022
Arrow International, LLC (a subsidiary of Teleflex, Inc.) Fallon Young Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K220280
Trade/Device Name: Arrow Stiffening Stylet Regulation Number: 21 CFR 870.1380 Regulation Name: Catheter Stylet Regulatory Class: Class II Product Code: DRB Dated: July 25, 2022 Received: July 28, 2022
Dear Fallon Young:
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,
for Hetal Odobasic Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below. |
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known) | K220280 |
|---|---|
| Device Name | Arrow Stiffening Stylet |
Indications for Use (Describe)
The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (6/20)
Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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Image /page/3/Picture/0 description: The image shows the logo for Arrow International. The word "ARROW" is in large, white, sans-serif font. Below it, in a smaller font, is the word "INTERNATIONAL". The background is a solid blue color.
510(k) SUMMARY
(as required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR 807.92)
Arrow Stiffening Stylet
1. Applicant Information:
| Name: | Arrow International LLC (subsidiary of Teleflex Incorporated) | |
|---|---|---|
| Address: | 3015 Carrington Mill Blvd | |
| Morrisville, NC 27560 USA | ||
| Contact Person: | Fallon Young | |
| Email: | fallon.young@teleflex.com | |
| Telephone Number: | (610) 984-7188 | |
| Fax Number: | (610) 478-3128 | |
| Date Prepared: | August 30, 2022 | |
| Device Name: | ||
| • Trade/Proprietary Name: | Arrow Stiffening Stylet | |
| • Classification Name: | Catheter, Stylet | |
| • CFR Number: | 21 CFR 870.1380 |
- . Device Class: II
- DRB Product Code: .
3. Predicate Device(s):
- . K182660: Galt Medical Corp's GaltTWS Stylet
4
4. Description of Device:
The Arrow Stiffening Stylet is a sterile, single use, percutaneous peripheral vasculature catheter stylet intended for transient use (up to 24 hours) to be placed within a catheter to render it stiff to aid in catheter placement. The proposed device will be delivered as a sterile accessory within a convenience kit for the Arrow Peripherally Inserted Central Catheter (PICC)s. The Stylet is a PTFE coated solid nitinol core wire with straight tip. The stylet is available in 0.015-0.017-inch diameters and in 29.5-inch length with distance markings along the stylet body.
The Arrow Stiffening Stylet is provided with an existing, commercially available flushable hub with side arm and slide clamp cleared under K790408. The flushable hub maintains the stylet position within the catheter during catheter placement, is intended to minimize blood loss during catheter introduction, and allows the clinician to flush through the catheter to aid in catheter placement, if needed. There is no change to the flushable hub cleared under K790408 introduced by this submission.
ನ. Indications for Use:
The Arrow Stiffening Stylet is intended to be placed inside a catheter to stiffen the catheter for placement.
Substantial Equivalence 6.
Intended Use / Indications for Use:
The intended use of the subject Arrow Stiffening Stylet is equivalent to the intended use of the predicate stylet. The subject and predicate devices are both intended to be placed within a catheter to stiffen the catheter for placement.
The indications for use of the Arrow Stiffening Stylet and the predicate stylet include the placement within a percutaneous catheter to stiffen the device for placement. The indications for use of the subject Arrow Stiffening Stylet are equivalent to the indications for use of the predicate stylet.
Technological Characteristics:
The subject Arrow Stiffening Stylet incorporates the same fundamental technology as the predicate stylet. The subject Arrow Stiffening Stylet and the predicate stylet are both metal body stylets of similar configurations with a flushable hub.
5
Table 2 summarizes the substantial equivalence comparison of the subject Arrow Stiffening Stylet with the predicate stylet.
| | Proposed Device
Arrow Stiffening Stylet | Predicate Device – K182660
GaltTWS Stylet |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Arrow Stiffening Stylet is intended
to be placed inside a catheter to stiffen
the catheter for placement. | The GaltTWS Stylet is a percutaneous catheter
stylet placed inside a catheter, lead, or cannula
to stiffen the device for placement. |
| Device Design Feature | | |
| Design | A solid nitinol wire | A stainless steel twisted/braided wire |
| Accessories | Existing, commercially available
flushable hub with side arm (K790408) | Existing, commercially available
flushable hub with side arm |
| Tip Type | Straight on both ends | Straight on both ends |
| Coating | PTFE | N/A |
| Core Material | Nitinol | Stainless Steel |
| Coil Material | N/A - no coil | N/A - no coil |
| Distal
Atraumatic Tip | Yes | Yes |
| Diameter | Diameter: 0.015-0.017 inch (0.39 mm-
0.44 mm) | Diameter: 0.012-0.015 inch (0.30 mm-0.39 mm) |
| Length | Length: 29.5 inch (75 cm) | Length: 30-72 inches (76 cm-182 cm) |
| Depth Control | Distance markings every 5 cm starting at
20 cm from distal end of stylet | No distance markings |
| Sterilization | | |
| Sterility | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility | | |
| Biocompatibility | Biocompatible materials used
(per ISO 10993-1) | Biocompatible materials used
(per ISO 10993-1) |
Table 2 - Substantial Equivalence Comparison Summary
7. Non-Clinical Performance Data.
The technological differences between the subject Arrow Stiffening Stylet and the predicate stylet have been evaluated through verification testing. The testing conducted that supports substantial equivalence of the subject Arrow Stiffening Stylet is listed below.
Testing Included:
- Mechanical/Physical testing in accordance with ISO 11070, Guidance ●
6
Documents, and Arrow International Internal Requirements:
- Surface: Extraneous Matter and Defects o
- Corrosion Resistance o
- Radio-detectability O
- Guide wire Fracture O
- Guide wire Flexure O
- Guide wire Tensile O
- Retainer Leak (Flushable Hub Interface) O
- Retainer Grip (Flushable Hub Interface) O
- Coating Integrity O
- Particulate O
- Torque Test O
- Stiffness O
- Removal Force from Catheter O
- Human Factors/Usability Testing ●
- Biocompatibility testing in accordance with ISO 10993-1:
- Cytotoxicity (MEM Elution) o
- Sensitization Kligman Maximization Test (polar and non-polar o extracts)
- Intracutaneous Injection (polar and non-polar extracts) o
- Acute Systemic Toxicity (polar and non-polar extracts) O
- Materials Mediated Pyrogenicity о
- Hemolysis (direct and indirect contact) O
- The Arrow Stiffening Stylet will be packaged as a convenience kit ● component with Arrow Peripherally Inserted Central Catheter (PICC) products. There are no changes to the packaging introduced by this submission.
8. Clinical Performance Data.
No human clinical data was required to support substantial equivalence.
9. Conclusion Regarding Substantial Equivalence
The information included in this premarket notification supports the substantial equivalence of the subject Arrow Stiffening Stylet to the
7
predicate stylet. The subject device has a substantially equivalent intended use, indications for use, and incorporates the same fundamental technology as the legally marketed predicate device to which it is compared.
Performance, human factors/usability, and biocompatibility testing has been conducted and has passed all acceptance criteria to verify that the proposed Arrow Stiffening Stylet meets its design, physical integrity, functional, and safety requirements and that any dimensional or material differences between it and the predicate stylet do not raise new issues of safety and effectiveness. The results of the testing included in this premarket notification support a determination of substantial equivalence.