(12 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe any characteristics typically associated with AI/ML-driven devices like training/test sets or performance metrics like AUC. The "predictive pulmonary function values" are likely calculated using established physiological models rather than AI/ML.
No
The device is used to monitor cardiopulmonary functions and provide predictive pulmonary function values, not to treat or cure a disease or condition.
Yes
The device is intended to monitor cardiopulmonary functions and provides predictive pulmonary function values, which are used to assess physiological states and can aid in determining a diagnosis or guiding treatment.
No
The device description explicitly states it is a "stationary device" and "electrically operated," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device function: The Shape-HF™ Cardiopulmonary Testing System monitors cardiopulmonary functions during stress testing and other procedures. It measures gas exchange directly from the patient's breath, not from a sample taken from the body.
- Intended Use: The intended use describes monitoring physiological functions in vivo (within the living body), not analyzing samples in vitro (outside the living body).
Therefore, the Shape-HF™ Cardiopulmonary Testing System falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Shape-HFTM Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.
Product codes (comma separated list FDA assigned to the subject device)
BTY
Device Description
The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions. The Shape-HF system is comparable to the Cortex Metalyzer 3BTM system (K993641). The device is software driven and electrically operated.
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
adults and children older than 14 years old
Intended User / Care Setting
laboratory or clinical facility setting
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)
Not Found
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.
Cortex Metalyzer 3BTM
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
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Koro722
510(k) Summary of Safety and Effectiveness (As required by 807.92(c))
| Submitter: | Shape Medical Systems, Inc.
5000 Township Parkway
St. Paul, MN 55110
Ph: 651.621.2990
MAR 31 2009 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | On behalf of Shape Medical Systems, Inc., the following
consultant is assigned the responsibility of submission
correspondence:
Darin Busch
AEIOMed, Inc.
1313 5th St. SE, Suite 205
Minneapolis, MN 55414
Phone: 612 455-0550
Fax: 612 455-0551
Email: darinb@aeiomed.com |
| Submission Date: | September 15, 2008 |
| Trade Name: | Shape-HFTM Cardiopulmonary Testing System |
| Classification Name: | Predictive Pulmonary Function Value Calculator (21 CFR
Section 868.1890) |
| Predicate Device: | Cortex Metalyzer 3BTM |
| Device Description and
Comparison: | The Shape-HF Cardiopulmonary Exercise Testing System
is a stationary device that monitors parameters during
laboratory or clinical conditions. The Shape-HF system is
comparable to the Cortex Metalyzer 3BTM system
(K993641).
The device is software driven and electrically operated. |
| Intended Use: | The Shape-HFTM Cardiopulmonary Testing System is a
pulmonary function stationary testing system intended to be
used to monitor cardiopulmonary functions during stress
testing, rehabilitation, sports medicine, and other related
procedures for which cardiopulmonary gas exchange |
| Differences and
Similarities: | provides predictive pulmonary function values that are
calculated based on the data obtained during testing. The
System can be used on adults and children older than 14
years old in a laboratory or clinical facility setting.
The Shape-HFTM Cardiopulmonary Testing System is
substantially equivalent to the predicate device. |
| Intended Use: | The intended use of the Shape-HF System and the predicate
device are equivalent. |
| Applications: | Both devices are used in applications such as stress testing,
rehabilitation, occupational medicine, sports medicine,
physiological research, and therapeutic assessment. |
| Usage location: | Both devices are designed for use in a laboratory or clinical
facility setting. |
| Technology: | The Shape-HF system and the predicate device have very
similar technology in their components. |
.
ﺔ ﻣﻨﻬﺎ ﺍﻟﻤﺮﺍﺟﻊ
.
1
Similarities:
Carbon dioxide sensor - Non-dispersive infrared in both systems. Oxygen sensor - Electrochemical fuel cell in both systems. Predictive value calculations - Both systems measure the same variables and then calculate values for pulmonary function. Intended population - Both systems are intended for use on adults or children over 14 years of age.
Differences:
Heart rate sensor - The Shape-HF System uses a pulse oximeter for sensing heart rate and the predicate device uses a Polar Belt. Both types are considered standard technology for heart rate sensing. Volume transducer - The Shape-HF System uses a fixed orifice, differential pressure pneumotach while the predicate uses a digital rotameter. Both methods are considered standard technology for measuring expired/inspired air flow.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shape Medical Systems, Incorporated C/o Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
MAR 3 1 2009
Re: K090722
Trade/Device Name: Shape-HF™ Cardiopulmonary Exercise Testing System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Valve Calculator Regulatory Class: II Product Code: BTY Dated: March 18, 2009 Received: March 19, 2009
Dear Mr. Lehtonen:
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.
3
Page 2 - Mr. Lehtonen
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 (OS) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smithe Y. Michael Omd.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Kogo ZAZ_
Device Name:
Shape-HFTM Cardiopulmonary Exercise Testing System
Indications for Use:
The Shape-HF™ Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090722
Shape-HF System 510(k)