(228 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the performance studies focus on standard electrical and safety testing, not algorithmic performance.
No
The device is described as a monitoring device that assesses and indicates cardiovascular status, and its intended use is to provide a non-invasive, continuous, real-time composite hemodynamic profile. It does not exert any direct therapeutic effect on the patient.
Yes
The device monitors cardiovascular status by assessing various parameters, and its predicate device is explicitly described as a "Non-Invasive Hemodynamic Diagnostic Device."
No
The device description explicitly states that the system is composed of a monitor, a transesophageal probe assembly, and a probe holder, indicating the presence of hardware components beyond just software.
Based on the provided information, the HemoSonic™ 200 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- HemoSonic™ 200 Function: The HemoSonic™ 200 is described as a monitoring device that non-invasively measures real-time descending aortic blood flow and other hemodynamic parameters directly within the patient. It uses a transesophageal probe.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The measurements are taken in vivo (within the living body).
Therefore, the HemoSonic™ 200 falls under the category of a medical device used for monitoring physiological parameters in vivo, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HemoSonic™ 200 is intended for use in patients with surgical, medical, or anesthetic risk to provide a non-invasive, continuous, real-time composite hemodynamic profile that indicates and monitors cardiovascular status by assessing contractility, flow, and resistance parameters.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transesophageal mode of operation: M, PWD, Combined (The system uses a combination of M-mode and PWD to determine both the diameter of and the flow within the aorta. The transesophageal probe contains two transducers, one dedicated to each function, and the two modes operate simultaneously (with appropriate pulse synchronization), and cannot be used independently within the normal operation of the equipment.)
Product codes (comma separated list FDA assigned to the subject device)
DPW, FED
Device Description
The HemoSonic™ 200 is a monitoring device that non-invasively measures real-time descending aortic blood flow and other hemodynamic parameters during anesthesia and intensive care. The HemoSonic™ 200 system is composed of a monitor, a transesophageal probe assembly and probe holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound
Anatomical Site
descending aortic (for blood flow)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesia and intensive care
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 following tests were performed to demonstrate substantial equivalence:
Comparative round trip insertion loss test,
Comparative pulsitile flow loop test,
EN 60601-1: Medical electrical equipment – Part 1: General requirements for safety – IEC 601-1,
EN 60601-1-2: Medical electrical equipment – Part 1: General requirements for safety. Collateral standard: Electromagnetic compatibility requirements and tests. IEC 601-1-2, and
IEC 60601-2-37: Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (Clause 42.3 tested under condition 2 only.)
Key results: The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.
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.
Sometec - Dynemo 3000 Non-Invasive Hemodynamic Diagnostic Device (K972798)
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
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "KO31153". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The numbers and letters are evenly spaced and clearly legible against the white background.
HemoSonic™ 200 Hemodynamic Monitor 510(k) Summary
| Submitter: | Arrow International Inc.
2400 Bernville Road
Reading, PA 19605 |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | William G. McLain
Manager, Regulatory Affairs
Phone: 610-378-0131
Fax: 610-478-3188
E-mail: bill.mclain@arrowintl.com |
| Date summary prepared: | 4/10/03 |
| Device trade name: | HemoSonic™ 200 Hemodynamic Monitor |
| Device common name: | Cardiac output monitor. |
| Device classification name: | FLOWMETER, BLOOD, CARDIOVASCULAR, DPW, at 21 CFR 870.2100 |
| Legally marketed devices to which the device is substantially equivalent: | Sometec - Dynemo 3000 Non-Invasive Hemodynamic Diagnostic Device (K972798) |
| Description of device: | The HemoSonic™ 200 is a monitoring device that non-invasively measures real-time descending aortic blood flow and other hemodynamic parameters during anesthesia and intensive care. The HemoSonic™ 200 system is composed of a monitor, a transesophageal probe assembly and probe holder |
| Intended use of the device: | The HemoSonic™ 200 is intended for use in patients with surgical, medical, or anesthetic risk to provide a non-invasive, continuous, real-time composite hemodynamic profile that indicates and monitors cardiovascular status by assessing contractility, flow, and resistance parameters. |
| Technological characteristics: | The technological characteristics are unchanged from the predicate device. |
| Performance tests: | The following tests were performed to demonstrate substantial equivalence:
☐ Comparative round trip insertion loss test,
☐ Comparative pulsitile flow loop test,
☐ EN 60601-1: Medical electrical equipment – Part 1:
General requirements for safety – IEC 601-1,
☐ EN 60601-1-2: Medical electrical equipment – Part 1:
General requirements for safety. Collateral standard:
Electromagnetic compatibility requirements and tests.
IEC 601-1-2, and
☐ IEC 60601-2-37: Medical electrical equipment – Part 2-
37: Particular requirements for the safety of ultrasonic
medical diagnostic and monitoring equipment (Clause
42.3 tested under condition 2 only.) |
| Conclusions: | The results of the performance tests demonstrate that the
device is substantially equivalent to the legally marketed
predicate device. |
1
HemoSonic™ 200 Hemodynamic Monitor 510(k) Summary
のお気になる。
and the comments of the comments of the comments of
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle with its wings spread.
NOV 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Arrow International, Inc. c/o Mr. William G. McLain Manager, Regulatory Affairs 2400 Bernville Road Reading, PA 19612
Re: K031153
HemoSonic™ 200 Hemodynamic Monitor Regulation Number: 21CFR 870.2100 and 876.1500 Regulation Name: Cardiovascular Blood Flowmeter and Endoscope Sheath Regulatory Class: Class II (two) Product Code: DPW and FED Dated: September 26, 2003 Received: September 29, 2003
Dear Mr. McLain:
We have reviewed your Section 510(k) premarket 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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the HemoSonic™ 200 Hemodynamic Monitor, as described in your premarket notification:
Model HSP 05065
3
Page 2 – Mr. William G. McLain
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.
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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health · Document Mail Center (HFZz401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. 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 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
4
Page 3 – Mr. William G. McLain
If you have any questions regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262.
Sincerely yours,
cMepax Myne
Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(1)
5
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Combined (specify) | Other (specify) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | |||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | P | P | P | |||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Combined Use - The system uses a combination of M-mode and PWD to determine both the diameter of and the flow within the aorta. The transesophageal probe contains two transducers, one dedicated to each function, and the two modes operate simultaneously (with appropriate pulse synchronization), and cannot be used independently within the normal operation of the equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
CMeleia Maye
(Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ko31153
Prescription Use (Per 21 CFR 801.109)