K Number
K063844
Device Name
REPROCESSED HEART STABILIZERS AND POSITIONERS
Manufacturer
Date Cleared
2007-03-15

(79 days)

Product Code
Regulation Number
870.4500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.
Device Description
Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction. Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.
More Information

No
The device description and performance studies focus on mechanical stabilization and positioning, with no mention of AI/ML technologies or data-driven analysis.

No
The device is used to stabilize and position the heart during cardiovascular surgery, which is a surgical tool rather than a therapeutic treatment itself.

No

The device description indicates that Heart Stabilizers and Positioners are used during cardiovascular surgery to stabilize, move, lift, and position the heart or localized areas of the heart. There is no mention of these devices being used to diagnose a condition or disease. They are tools for surgical manipulation, not diagnosis.

No

The device description clearly details physical components such as tissue stabilizers, articulating arms, mounting clamps, suction pods, and a stopcock, indicating it is a hardware device used in surgery.

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 about a person's health. This information is typically used for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states that this device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. It is a surgical tool used directly on the patient's organ.
  • Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.

Therefore, this device falls under the category of a surgical instrument or medical device used for intervention, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

Product codes

NQG

Device Description

Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction.
Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

heart

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

Representative samples of reprocessed heart stabilizers and positioners underwent functional testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

Key Metrics

Not Found

Predicate Device(s)

K964445

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair

For Reprocessed Heart Stabilizers And Positioners

K063844

MAR 1 5 2007

II. SUMMARY AND CERTIFICATION

510(k) Summary A.

Submitter:SterilMed, Inc.
Contact Person:Dennis Toussaint
11400 73rd Avenue North
Maple Grove, MN 55369
Ph: 888-856-4870
Fax: 763-488-3350
Date Prepared:December 22, 2006
Trade Name:Reprocessed Heart Stabilizers and Positioners
Classification Name:Cardiovascular Surgical Instruments
Classification Number:Class I, 21 CFR 870.4500
Product Code:NQG

| Predicate
Devices: | The reprocessed heart stabilizers and positioners are substantially equivalent to the
Medtronic Octopus Tissue Stabilizer (and positioner) (K964445). The non-
reprocessed heart stabilizers and positioners are Class I, 510(k) exempt devices. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers
attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to
15 mm apart, nominally. The articulating arm fastens to a retractor by use of a
mounting clamp. The arm is tightened and loosened by a large knob on the proximal
end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc
fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With
the pods placed on either side of the anastamosis site, suction is applied to stabilize the
tissue.. A stopcock provides control of suction. |
| | Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to
facilitate access to and enhance exposure of the coronary arteries for coronary artery
bypass procedures. The device is retractor-based and incorporates a silicone suction
apparatus, an articulating arm and a mounting clamp. The silicone apparatus is
attached to the surface of the heart by the application of regulated vacuum. The
mounting clamp has been designed to be compatible with most adult median
sternotomy retractors. |
| Intended Use: | Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift,
and position the heart during cardiovascular surgery. |
| Functional and
Safety Testing: | Representative samples of reprocessed heart stabilizers and positioners underwent
functional testing to demonstrate appropriate functional characteristics. Process
validation testing was done to validate the cleaning and sterilization procedures as well
as device packaging. In addition, the manufacturing process includes visual and
functional testing of all products produced. |

1

For Reprocessed Heart Stabilizers And Positioners

Conclusion:The reprocessed heart stabilizers and positioners are substantially equivalent to the Octopus Tissue Stabilizer (and Positioner) (K964445) manufactured by Medtronic. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

. . . .

2

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 stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, topped by wings. The caduceus is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

MAR 1 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed Inc. c/o Mr. Dennis Toussaint Director of Regulatory Affairs 11400 73td Avenue North Maple Grove, MN 55369

Re: K063844

Octopus 3.0, 4.0, and 4.3 Stabilizers, Starfish 2 Positioner, and Urchin Positioner Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I Product Code: NOG Dated: February 23, 2007 Received: February 26, 2007

Dear Mr. Toussaint:

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. Dennis Toussaint

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 (240) 276-0120. 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 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,

ina R. Luchtner

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): K063844

Device Name: Reprocessed Heart Stabilizers and Positioners

Indications For Use:

Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.

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)

Duna R. Jahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number K063844

Page 1 of 1

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ProCodeFamilyModel
NQGMedtronic Heart
Stabilizers and
PositionersOctopus 3.0 Stabilizer
Octopus 4.0 Stabilizer
Octopus 4.3 Stabilizer
Starfish 2 Positioner
Urchin Positioner