(76 days)
Not Found
No
The summary describes a mechanical adapter for a sheath introducer and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an adapter for a sheath introducer, facilitating access for other devices but not directly performing a therapeutic function itself.
No
Explanation: The device description states it is an accessory for venous access and catheter introduction, facilitating a broader range of device sizes to be placed. There is no mention of it being used to diagnose conditions or process diagnostic images.
No
The device description clearly states it is an "adapter" that is "attached to the hemostasis valve of the sheath introducer," indicating it is a physical component, not software. The performance studies also focus on physical properties like "Leak resistance, Insertion / drag force, Cap torsion."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate venous access and catheter introduction into the central circulation. This is a procedure performed in vivo (within the body) for therapeutic or diagnostic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The device is an accessory to a sheath introducer, which is used for inserting catheters into blood vessels. This is a medical device used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural, assisting in the insertion of other medical devices into the body.
N/A
Intended Use / Indications for Use
The Arrow Sheath Adapter is utilized in conjunction with onepiece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The proposed device is an accessory to Arrow's existing Percutaneous Sheath Introducer (PSI) (K780532). The adapter is attached to the hemostasis valve of the sheath introducer allowing a broader range of device sizes to be placed through the introducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Tests were performed to demonstrate substantial equivalence in the following areas:
• Leak resistance
• Insertion / drag force
• Cap torsion
The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.
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.
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
Special 510(k)
SECTION 3. 510(K) SUMMARY
| Submitter: | ARROW International, Inc.
2400 Bernville Road
Reading, PA 19605-9607 USA |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Brandon Epting
Regulatory Associate
Phone: 610-378-0131, ext. 3498
Fax: 610-374-5360
Email: brandon.epting@arrowintl.com |
| Date summary prepared: | May 20, 2002 |
| Device trade name: | Sheath Adapter |
| Device common name: | Sheath Adapter |
| Device classification name: | Catheter Introducer |
| Legally marketed devices to which
the device is substantially equivalent: | Arrow Percutaneous Sheath Introducer (K780532)
Thomas Medical Products Tuohy-Borst Adapter (K904608) |
| Description of the device: | The proposed device is an accessory to Arrow's existing
Percutaneous Sheath Introducer (PSI) (K780532). The
adapter is attached to the hemostasis valve of the sheath
introducer allowing a broader range of device sizes to be
placed through the introducer. |
| Intended use of the device: | When attached to the hub of the PSI, a hemostasis valve in
the sheath adapter device permits the insertion of a 4 Fr to
7 Fr catheter through the PSI and prevents leaking and
bleedback. The Tuohy-Borst mechanism in the sheath
adapter can be tightened to prevent catheter migration and
to prevent leakage and bleedback. |
| Technological characteristics: | The proposed sheath adapter has the same technological
characteristics as the predicate devices. |
| Performance tests: | Tests were performed to demonstrate substantial
equivalence in the following areas:
• Leak resistance
• Insertion / drag force
• Cap torsion |
| Conclusions: | The results of the laboratory tests demonstrate that the
device is as safe and effective as the legally marketed
predicate devices. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper portion of the circle.
Public Health Service
AUG 0 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arrow International, Inc. c/o Mr. Brandon Epting Regulatory Affairs Associate 2400 Bernville Road Reading, PA 19605
Re: K021723
Trade Name: Sheath Adapter Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: July 25, 2002 Received: July 26, 2002
Dear Mr. Epting:
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. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Brandon Epting
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dea. Tortell
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
.
of
Page
SECTION 7. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Sheath Adapter
Indications for Use:
The Arrow Sheath Adapter is utilized in conjunction with onepiece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021723
Prescription Use
(Per 21 CFR 801.109)