(388 days)
The Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various cardiovascular devices into the left side of the heart through the interatrial septum.
The Arrow Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set consists of a long radiopaque wire-reinforced sheath and dilator with curved distal tips for positioning against the atrial septum.. The introducer sheath contains an integral hemostasis valve and side port with a three-way stopcock. The dilator accommodates a curved transseptal needle (18ga. needle for adults and 19ga. needle for pediatrics) and has a long gradual tapered tip that steps up to the OD for ease of insertion.
The provided text describes a 510(k) submission for a medical device (Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven device evaluation. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and biocompatibility testing.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's an attempt to answer the questions based only on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility of sheath/dilator with the Brockenbrough needle assembly | Comparable performance to the Bard predicate device |
| Kink radius | Comparable performance to the Bard predicate device |
| Tensile strength of sheath blank material | Comparable performance to the Bard predicate device |
| "In use" simulation test advancing and retracting the Brockenbrough needle in the sheath introducer | Comparable performance to the Bard predicate device |
| Tensile test results all bonds and joints | Comparable performance to the Bard predicate device |
| Flexibility and maneuverability test | Comparable performance to the Bard predicate device |
| Biocompatibility | Additional biocompatibility testing was provided (details not specified) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests. The text mentions "test results" but no specific number of units tested.
- Data Provenance: Not specified. The tests are described as "nonclinical test results," implying laboratory or bench testing rather than clinical data from human subjects or specific geographical locations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The tests described are non-clinical, evaluating physical properties and performance against a predicate device, not relying on expert interpretation of medical data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for the non-clinical engineering tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not describe an AI/ML device or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests appears to be established by engineering specifications and comparative performance relative to a predicate device. For example, "comparability of sheath/dilator with the Brockenbrough needle assembly" implies the predicate device's performance as the benchmark.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device, and thus no training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML device, and thus no training set.
{0}------------------------------------------------
FEB 1 3 1998
510(K) SUMMARY - K970229
ARROW TRANSSEPTAL SUPER ARROW-FLEX® PERCUTANEOUS SHEATH INTRODUCER SET
Date: January 16, 1997 Submitted By: Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International, Inc. 3000 Bernville Road Reading, PA 19605 Direct Phone: FAX: (610) 478-3172
Trade name
Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set, consisting of the following:
- One radiopaque Super Arrow-Flex® sheath with integral side port/hemostasis valve, 3-way . luer-lock stopcock and radiopaque marker band
- One vessel dilator .
Common or classification name
The device was originally listed as Introducer, catheter, 74 DYB, and was subsequently classified in class II at CFR 870.1340, catheter introducer.
Common names are sheath introducer, percutaneous sheath introducer, catheter introducer, sheath, introducer, PSI.
Substantial equivalence
The device is substantially equivalent to the following legally marketed products:
-
- Arrow Super Arrow-Flex® percutaneous sheath introducer sets
-
- Bard Mullins transseptal catheter introducer set
-
- Daig Fast-Cath™ transseptal introducer
This device is identical in construction to the Arrow predicate device except for a curved sheath and dilator, plus tip marker band.
Description:
The Arrow Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set consists of a long radiopaque wire-reinforced sheath and dilator with curved distal tips for positioning against the atrial septum.. The introducer sheath contains an integral hemostasis valve and side port with a three-way stopcock. The dilator accommodates a curved transseptal needle (18ga. needle for adults and 19ga. needle for pediatrics) and has a long gradual tapered tip that steps up to the OD for ease of insertion.
{1}------------------------------------------------
Indications for use:
The Arrow Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set is intended for use in the hospital catheterization laboratory for the perculaneous introduction of various cardiovascular devices into the left side of the heart through the interatrial septum.
The device has comparable technological characteristics to the predicate devices.
The nonclinical test results in the submission showing comparable performance to the Bard predicate device are as follows:
-
- Compatibility of sheath/dilator with the Brockenbrough needle assembly
-
- Kink radius
-
- Tensile strength of sheath blank material
-
- "In use" simulation test advancing and retracting the Brockenbrough needle in the sheath introducer
100
-
- Tensile test results all bonds and joints
-
- Flexibility and maneuverability test
Additional biocompatibility testing was also provided in the submission.
97075
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 1998
Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International 2400 Bernville Road Reading, PA 19605
K970229 Re : Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set Regulatory Class: II (two) Product Code: 74 DYB Dated: January 30, 1998 Received: February 4, 1998
Dear Mr. Nickel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahor
Thomas J. Callawan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
P.O. Box 12888 Reading, PA 19612
Image /page/4/Picture/1 description: The image shows the word "ARROW" in large, bold, black letters. Below the word "ARROW" is the word "INTERNATIONAL" in smaller, thinner, black letters. The words appear to be a logo for a company.
3000 Bernville Road Reading, PA 19605
(610) 378-0131 FAX: (610) 374-5360
Section 11 - Indications
The Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer set, in intended for The Arrow Transseptal Super Anow Hoxe Porculaneous introduction of Various
use in the hospital catheterization laboratory for the percularies introduction of various use in the nospital Cathetonzulor laborator J for the phrough the interatrial septum.
cardiovascular devices into the left side of the heart through the interatrial septum.
Ta A N
(Division Sign-Off) Division of Cardiovascular, R and Neurological Devices 510(k) Number
9610
§ 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).