(30 days)
No
The description focuses on a fiber optic pressure sensor and measurement system, with no mention of AI or ML for data processing or interpretation.
Yes
The device is designed to provide cardiac assist therapy for various acute and chronic cardiac conditions, which aligns with the definition of a therapeutic device.
Yes
This device is designed to measure and display arterial pressure. While this information is used for therapy (cardiac assist), the fundamental function of measuring a physiological parameter for clinical use qualifies it as a diagnostic device.
No
The device description clearly outlines physical components including a catheter, fiber optic sensor, and a sensor measurement system, indicating it is a hardware device with potential software components for data display and output.
Based on the provided text, 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.
- Device Function: The Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System is a device that is inserted directly into the aorta (an anatomical site within the body) to provide cardiac assist therapy and measure arterial pressure in vivo (within the living body).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and measures parameters within the body.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:
- a. Acute Coronary Syndrome
- b. Cardiac and Non-Cardiac Surgery
- c. Complications of Heart Failure
Product codes (comma separated list FDA assigned to the subject device)
DSP
Device Description
IAB's are designed to provide cardiac assist therapy. In cardiac assist therapy a standard electronic pressure transducer can be connected externally to the central lumen of an IAB as a means of monitoring arterial pressure.
The purpose of the IAB device modification is to provide an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter, as opposed to a standard electronic pressure transducer that is connected externally to the central lumen of an IAB.
A pressure sensor is attached to a flexible optical fiber in the IAB catheter. The sensor is positioned within the tip of the IAB catheter and the fiber runs the length of the inner lumen, exiting at the trifurcation and attaches to an optical connector. The sensor in the IAB catheter optically transmits light to a sensor measurement system. The sensor measurement system displays and outputs an arterial pressure.
Because the fiber optic sensor is positioned directly in the aorta, an arterial pressure can be directly obtained as opposed to obtaining arterial pressure readings through the end of a fluid-filled column and transducer. Additionally the fiber optical not electrical, therefore, the pressure signal is immune to any electrical noiselinterference that can affect a standard electronic pressure transducer. The fiber optic measurement system outputs the pressure via a digital or analog signal. The output signal can be input into a patient monitoring system or Intra-Aortic Balloon Pump (IABP).
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)
The results of the laboratory tests demonstrate that the device is substantially equivalent.
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.
K000729, K963920, K993966, K981660
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
§ 870.3535 Intra-aortic balloon and control system.
(a)
Identification. An intra-aortic balloon and control system is a prescription device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.(b)
Classification. (1) Class II (special controls) when the device is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure. The special controls for this device are:(i) Appropriate analysis and non-clinical testing must be conducted to validate electromagnetic compatibility and electrical safety of the device;
(ii) Software verification, validation, and hazard analysis must be performed;
(iii) The device must be demonstrated to be biocompatible;
(iv) Sterility and shelf-life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components;
(v) Non-clinical performance evaluation of the device must demonstrate mechanical integrity, durability, and reliability to support its intended purpose; and
(vi) Labeling must include a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(2) Class III (premarket approval) when the device is indicated for septic shock and pulsatile flow generation.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 31, 2014, for any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976, or that has, on or before March 31, 2014, been found to be substantially equivalent to any intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation that was in commercial distribution before May 28, 1976. Any other intra-aortic balloon and control system indicated for septic shock or pulsatile flow generation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2016
Arrow International, Inc. c/o Mr. William Paquin Quality Assurance/Regulatory Affairs Manager 9 Plymouth Street Everett, MA 02149
Re: K021462
Trade/Device Name: Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-aortic balloon and control system Regulatory Class: Class II Product Code: DSP Dated: May 1, 2002 Received: May 7, 2002
Dear William Paquin:
This letter corrects our substantially equivalent letter of June 6, 2002.
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. 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
1
Page 2 - William Paquin
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 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDeyices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric E. Richardson -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K021462
Device Name
Arrow Intra-Aortic Balloon (IAB) Catheter With A Fiber Optic Sensor And A Measurement System
Indications for Use (Describe)
The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:
- a. Acute Coronary Syndrome
- b. Cardiac and Non-Cardiac Surgery
- c. Complications of Heart Failure
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the word "Teleflex" in a stylized, bold, sans-serif font. The letters are black, and there is a registered trademark symbol to the right of the "x". The word appears to be a logo or brand name.
Arrow International, Inc
9 Plymouth Street Everett. MA 02149 USA 617-389-6400 Phone: Fax: 617-387-2157
510(k) Summary K021462
Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System
Date Summary Updated: July 28, 2015
A. Submitter's Name:
Arrow International, Inc. 9 Plymouth Street, Everett, MA 02149
Updated Correspondent Address: Fusun Tufan
Senior Regulatory Affairs Manager Arrow International. Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
B. Company Contact
Michael Malis Director RAIQA Arrow International, Inc. 16 Elizabeth Drive, Chelmsford, MA 01824 Phone (978)250-5100 Fax (978)250-5105
C. Device Name
| Trade Name: | Arrow Intra-Aortic Balloon (IAB) Catheter with A Fiber Optic Sensor
and A Measurement System |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Intra-Aortic Balloon (IAB) with a Fiber Optic Sensor and Measurement
System |
| Classification Name: | Balloon, Intra-Aortic and Control System |
D. Predicate Devices
The following table contains the predicate devices which Arrow claims substantial equivalence. Table 1: Predicate Devices
| 510(k) | Intra-Aortic Balloon Description |
|---|---|
| K000729 | IAB 8Fr, 30cc Arrow Ultra 8 |
| K000729 | IAB 8Fr, 40cc Arrow Ultra 8 |
| K963920 | IAB 8Fr, 30cc Arrow NarrowFlex Universal |
| K993966 | IAB 8Fr, 40cc Arrow NarrowFlex Universal |
| K981660 | IAB 8Fr, 40cc RediGuard Arrow ArmorGlide |
The fiber optic sensor and measurement system is technologically equivalent to the following device:
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Image /page/4/Picture/0 description: The image shows the word "Teleflex" in a stylized, bold, sans-serif font. The "T" in "Teleflex" is unique, with a horizontal bar extending to the left. A circled "R" trademark symbol appears to the right of the "x" in "Teleflex", indicating that the name is a registered trademark.
- Camino Ventrix Subdural Tunneling Pressure Monitoring Kit from Camino NeuroCare, 5955 Pacific Center Blvd., San Diego, California 92121, Premarket Notification K982702.
E. Description of Device
IAB's are designed to provide cardiac assist therapy. In cardiac assist therapy a standard electronic pressure transducer can be connected externally to the central lumen of an IAB as a means of monitoring arterial pressure.
The purpose of the IAB device modification is to provide an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter, as opposed to a standard electronic pressure transducer that is connected externally to the central lumen of an IAB.
A pressure sensor is attached to a flexible optical fiber in the IAB catheter. The sensor is positioned within the tip of the IAB catheter and the fiber runs the length of the inner lumen, exiting at the trifurcation and attaches to an optical connector. The sensor in the IAB catheter optically transmits light to a sensor measurement system. The sensor measurement system displays and outputs an arterial pressure.
Because the fiber optic sensor is positioned directly in the aorta, an arterial pressure can be directly obtained as opposed to obtaining arterial pressure readings through the end of a fluid-filled column and transducer. Additionally the fiber optical not electrical, therefore, the pressure signal is immune to any electrical noiselinterference that can affect a standard electronic pressure transducer. The fiber optic measurement system outputs the pressure via a digital or analog signal. The output signal can be input into a patient monitoring system or Intra-Aortic Balloon Pump (IABP).
F. Indications for Use
The Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:
- a. Acute Coronary Syndrome
- b. Cardiac and Non-Cardiac Surgery
- C. Complications of Heart Failure
G. Technological Characteristics
The device has similar technological characteristics as previously cleared pressure sensors.
The results of the laboratory tests demonstrate that the device is substantially equivalent.