(181 days)
C3600, C3601
Not Found
No
The description focuses on the tubing's function for irrigation and aspiration, and there is no mention of AI, ML, or related concepts.
No
The device is described as "Manifold Tubing" that links a system console to a hand-piece for irrigation and aspiration during surgery. It does not directly provide a therapeutic effect but rather supports a surgical procedure.
No
The device description clearly states its function as "Manifold Tubing" for an aspirator system, providing "conduits for both irrigation and aspiration of the surgical site." This describes a functional component of a surgical tool, not a device used for diagnosis.
No
The device is described as "tubing sets" which are physical components used for irrigation and aspiration, clearly indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as "Manifold Tubing" for an "Ultrasonic Aspirator System." Its function is to provide irrigation and aspiration during surgery. This is a surgical device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its role as conduits for irrigation and aspiration during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a surgical instrument/accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.
Product codes
LFL
Device Description
These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate handpiece, providing conduits for both irrigation and aspiration of the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
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)
Safety and hazard analysis has determined that the hazard conditions for the Kirwan disposable manifold tubing sets range in the low-to-moderate level and for this reason are acceptable. Kirwan 40-3600, 23 kHz and 40-3601, 36 kHz Manifold Tubing devices have been tested and manufactured in accordance with prevailing standards and guidelines in order to assure safety and efficacy. Kirwan manifold tubing sets have been found to comply with the requirements of the applicable sections within the following standards and guidelines; ISO 11137, Sterilization of health care products Requirements for validation and routine control-radiation sterilization. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
C3600, 23 kHz Manifold Tubing (Integra LifeSciences), C3601, 36 kHz Manifold Tubing (Integra LifeSciences)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for Kirvan Surgical Products. The logo features a caduceus symbol in a square to the left of the word "KIRVAN" in large, outlined block letters. To the right of "KIRVAN" is a registered trademark symbol and the words "SURGICAL PRODUCTS" stacked on top of each other in a smaller, bolder font.
AUG - 7 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
{as required by 21 CFR, section 807.92( c )}
FOR
KIRWAN DISPOSABLE MANIFOLD TUBING SET
MODELS: 40-3600, 23 kHz, and 40-36001, 36 kHz
Common name: Irrigation / Aspiration Lines
Classification name: Unclassified
Product code: LFL.
Devices Class: Class I
These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate handpiece, providing conduits for both irrigation and aspiration of the surgical site.
Technological safety and effectiveness is established by the fact that these tubing sets do not contain any new technological risks or characteristics when compared to the legally marketed device offered here as predicate. They are manufactured according to prevailing standards and represent a technology that has existed in clinical settings for over 30-years.
There are no applicable performance standards listed for these devices under Section 514 of the Food, drug and Cosmetic Act. Nonetheless, Kirwan 40-3600, 23 kHz and 40-3601, 36 kHz Manifold Tubing devices have been tested and
Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario, Regulatory Affairs Manager Date prepared: 2/1/2007
1
manufactured in accordance with prevailing standards and guidelines in order to assure safety and efficacy. Kirwan manifold tubing sets have been found to comply with the requirements of the applicable sections within the following standards and guidelines;
- ISO 11137, Sterilization of health care products Requirements for 트 validation and routine control-radiation sterilization.
- ISO 10993-1, Biological evaluation of medical devices Part 1: . Evaluation and testing.
Safety and hazard analysis has determined that the hazard conditions for the Kirwan disposable manifold tubing sets range in the low-to-moderate level and for this reason are acceptable.
Therefore, the Kirwan 40-3600, 23 kHz and 40-3601, 36 kHz Disposable Manifold Tubing Set devices are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates;
- C3600, 23 kHz Manifold Tubing (Integra LifeSciences). 트
- I C3601, 36 kHz Manifold Tubing (Integra LifeSciences).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design of three human figures connected by flowing lines, representing health and well-being. The figures are arranged in a vertical stack, with the top figure slightly larger than the others. Encircling the figures is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kirwan Surgical Products, Inc. % Mr. Kevin Prario Regulatory Affairs manager 180 Enterprise Drive Marshfield, Massachusetts 05050
AUG - 7 2007
Re: K070360
Trade/Device Name: Models: 40-3600/01, Kirwan Disposable Manifold Tubing Set Regulatory Class: Unclassified Product Code: LFL Dated: July 30, 2007 Received: July 31, 2007
Dear Mr. Prario:
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.
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
3
Page 2 – Mr. Kevin Prario
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) 276-0115 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,
Mark H. Milburn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Models: 40-3600/01, Kirwan Disposable Manifold Tubing Set
Indications for Use:
These tubing sets are designed to function as Manifold Tubing for the CUSA EXcel™ Ultrasonic Aspirator System i.e., both 23 kHz and 36 kHz hand-piece models. As Manifold Tubing they link the system console to the appropriate hand-piece, providing for both irrigation and aspiration of the surgical site.
| Prescription Use X
| (Part 21 CFR 801 Subpart D) | AND |
|---|---|
| ---------------------------------------------------------- | ----- |
DIOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070360
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