(226 days)
Not Found
No
The summary describes mechanical devices for surgical stabilization and positioning, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used to stabilize and position the heart during surgery, which directly aids in a medical procedure to treat a condition. While it doesn't administer therapy itself (like a drug or radiation), its function is to facilitate the therapeutic surgical intervention.
No
The device is described as aiding in surgical procedures by retracting and stabilizing the heart. Its intended use and description focus on providing physical access and stability during surgery, not on diagnosing medical conditions.
No
The device description explicitly lists physical components (tissue stabilizer, heart positioner, sternum retractor blades) and describes their mechanical functions (retraction, stabilization, positioning, vacuum suction). The performance studies focus on bench and laboratory testing of these physical components and processes like reprocessing and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The description clearly states that this device is used during surgery on a beating heart to stabilize and position it. It is a surgical tool used directly on the patient's organ.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or providing diagnostic information based on such analysis.
The device is a surgical instrument used for mechanical manipulation of the heart during a procedure, not for in vitro testing of samples.
N/A
Intended Use / Indications for Use
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Product codes (comma separated list FDA assigned to the subject device)
NQG
Device Description
Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, thoracic cavity
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)
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended.
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
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
.
2007
SECTION 5: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions
10232 South 51st Street
Phoenix, Arizona 85044 | AUG 17 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Contact: | Katie Bray
RA Specialist/Biomedical Engineer
(480) 763-5300 (o)
(480) 763-6089 (f)
kbray@ascenths.com | |
| Date of preparation: | December 29, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Cardiac Stabilization and
Positioning Devices | |
| | Classification Name: Cardiovascular surgical instruments | |
| Predicate Device | 510(k) Title
K992833 Vacuum Assist Stabilizer
K982419 CTS Heart-Lift Balloon Positioner | Manufacturer
CardioThoracic Systems (Guidant)
CardioThoracic Systems (Guidant) |
| Note: These are class I devices that do not require a 510(k) for original (brand new) devices. Therefore, the predicate device may not have a filed 510(k) from the original manufacturer. | | |
| Device description: | Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades. | |
| Indications for Use: | Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart. | |
| Technological
characteristics: | The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the | |
| CONFIDENTIAL | Ascent Healthcare Solutions | Page 11 |
1
predicate devices. The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Ascent Healthcare Solutions's reprocessing of Cardiac Stabilization and Positioning Devices includes removal of adherent visible soil and decontamination. Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices. This included the following tests:
- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- . Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended.
Conclusion:
Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Cardiac Stabilization and Positioning Devices) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044
Re: K070034
Reprocessed Guidant (CTS) Cardiac Stabilization and Positioning Devices Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I non-exempt Product Code: NQG Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Bray:
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 - Ms. Katie Bray
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| ProCode | Family | Model |
|---|---|---|
| NQQ | Guidant Heart | |
| Stabilizers and | ||
| Positioners | Ultima Std Foot Stabilizer | |
| (OM-2001) | ||
| Ultima Mechanical | ||
| Stabilizer with Std Blades | ||
| (OM-2001S) | ||
| Ultima Mechanical | ||
| Stabilizer Left Offset w/Std | ||
| Blades (OM-2003S) | ||
| Acrobat Mechanical | ||
| Stabilizer w/Std Blades | ||
| (OM-6000S) | ||
| Acrobat SUV Vacuum | ||
| Stabilizer (OM-9000) | ||
| Acrobat V Vacuum | ||
| Stabilizer (OM-9100) | ||
| Acrobat SUV Vacuum | ||
| Stabilizer w/Std Blades and | ||
| Tubing (OM-9000S) | ||
| Xpose 3 Access Device | ||
| (XP-3000) | ||
| Xpose 4 Access Device | ||
| (XP-4000) | ||
| AccessRail Standard Blade | ||
| Platform (SB-1000) |
:
5
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 《○フ○○ 34
Device Name: Reprocessed Guidant Cardiac Stabilization and Positioning Devices
Indications For Use:
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Prescription Use - X --(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| CONFIDENTIAL | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Ascent Healthcare Solutions | |
| Repressed Dantoic Stabilization Devices | |
| Traditional 510(k) | |
| 76054 | |
| Page 10 |