(60 days)
No
The device description focuses on mechanical components and suction-based stabilization, with no mention of AI/ML terms or functionalities.
No.
The device's intended use is to stabilize the epicardial surface of the heart during surgery, which is a supportive role in a surgical procedure, not a direct treatment or therapy for a disease or condition.
No
The device description indicates it is a surgical tool used to stabilize the heart during surgery, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines physical components such as a suction-based tissue stabilizer, collapsible pod assembly, rigid shaft, articulating links, suction lines, vacuum lines, and an irrigator. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the Medtronic Octopus TE Stabilizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description clearly states the device is used to stabilize the epicardial surface of the non-arrested heart during surgery. This is a direct interaction with the patient's organ, not the analysis of a specimen taken from the patient.
- The intended use and device description focus on a surgical procedure. The device is used in an operating room environment by medical professionals to physically stabilize the heart during coronary artery surgery. This is a therapeutic/surgical intervention, not a diagnostic test performed on a sample.
The information provided aligns with a surgical device used for stabilization during a procedure, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
Product codes (comma separated list FDA assigned to the subject device)
MWS
Device Description
The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epicardial surface of the non-arrested heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals in operating room environments.
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.
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
§ 870.4500 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
JUL 1 9 2004
510(k) Summary
: -
| Submitter: | Medtronic Cardiac Surgery Technologies
7601 Northland Drive
Minneapolis, MN 55428 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott Cundy |
| | Telephone: (763) 391-9941
Fax: (763) 391-9279 |
| Date Prepared: | 18 May 2004 |
| Trade Name: | Medtronic Octopus® TE Stabilizer & Accessories |
| Common Name: | Cardiovascular Surgical Instrument/Heart Stabilizer |
| Equivalence to: | The Medtronic Octopus TE Stabilizer & Accessories are
substantially equivalent in patient population, intended use,
function and basic system components to the Medtronic Octopus
Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum
Assist Stabilizer (K992833). |
| | The Medtronic Octopus TE Stabilizer has an optional irrigator
(lavage) that is designed to provide drip irrigation for improved
visibility. Said irrigator has a similar surgical site cleansing
indication for use as existing jet lavage systems such as the
Medtronic Clearview Blower/Misted (K973485). |
| Description: | The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing
System is a suction-based tissue stabilizer with a collapsible pod
assembly, a rigid shaft and 5 articulating links designed to enable
transfer into the thoracic cavity via a 12 mm thoracic port or
traditional sternotomy access. It is comprised of four distinct
elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the
Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus
TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator
(optional). |
| | The Medtronic Octopus TE Heart Stabilizer is secured to a flexible
arm and universal mounting rail, which attached to the operating
table rail. Vacuum is delivered to the pod assembly by a
disposable suction line inserted through the shaft of the stabilizer
and a disposable vacuum line that connects the stabilizer to the
vacuum source. The accessories are sold separately. |
| Intended Use: | The Medtronic Octopus TE Stabilizer is used to stabilize the
epicardial surface of the non-arrested heart during coronary artery
surgery. It is intended to be used by trained medical professionals
in operating room environments. |
| Technological
Characteristics: | Comparisons between the new and predicate devices shows that
technological characteristics (i.e. device design and principal of
operation) are substantially equivalent. |
| Conclusion: | The Medtronic Octopus TE Stabilizer was found to be
substantially equivalent in patient population, intended use,
principal of operation and basic system components to the
predicate devices. |
1
.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2004
Medtronic Cardiac Surgery Technologies c/o Davis D. Cox, Ph.D. Principal Regulatory Affairs Specialist 7601 Northland Drive Minneapolis, MN 55428-1088
Re: K041338
Octopus TE Tissue Stabilizer Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I (one) Product Code: MWS Dated: July 8, 2004 Received: July 9, 2004
Dear Dr. Cox:
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 - Davis D. Cox, Ph.D.
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 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) you may obtain. 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,
Dvina R. buchanan
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K041338
Octopus TE Tissue Stabilizer Device Name:
Indications for Use:
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
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)
のお気になる。
R. Vochner
)ivision Sign-Off) ision of Cardiovascular Devices
) Number K041338