(39 days)
Not Found
No
The device description and intended use describe a simple mechanical instrument (cannula) for suction and infusion. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is used for suction and infusion of fluids and tissue during surgical procedures, which are instrumental functions rather than direct therapeutic actions. It facilitates a medical procedure but does not inherently treat or cure a disease or condition.
No
Explanation: The device is described as an instrument used for suction and infusion of fluids during surgical procedures, which are interventional rather than diagnostic functions.
No
The device description clearly states it is a hollow stainless steel tube with a handle, which is a physical hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures." This describes a surgical instrument used directly on the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The description of "hollow stainless steel tubes" with different tips and sizes aligns with surgical cannulas, not diagnostic reagents or instruments used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical for fluid and tissue management during surgery.
N/A
Intended Use / Indications for Use
The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.
The LySonix Suction and Infusion Cannulas are inserted under the skin during various types of surgical procedures and may be connected to a suction or aspiration apparatus if desired. The Suction Cannula can then be used to suction out waste fluids or aspirate unwanted tissue. The Infusion Cannulas are used to infuse fluids such as medications or saline during surgery. The Suction/Aspiration and Infusion cannulas are not indicated for use with any specific surgical specialty, but are considered general surgical tools.
Product codes (comma separated list FDA assigned to the subject device)
FGY
Device Description
The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The Suction and Infusion Cannulas are each available in three cannula lengths and four diameters. The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile.
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
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)
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.
K962525, K832520, K914526, 926479, K862936, K861878
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K472958
510(k) SUMMARY LYSONIX SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION CANNULAS
SFF 9 9 1007
I. NAME OF SUBMITTER
LySonix, Inc. 1170 Mark Avenue Carpinteria, CA 93013
Contact person: Michael Sarrasin, JD (805) 684-0409 phone (805) 684-0170 fax
II. DEVICE NAME AND CLASSIFICATION
LySonix Suction/Aspiration Cannulas (TTD Delta Scavenger Proprietary Name: Cannulas) LySonix Infusion Cannulas (Infusion Diamond Cannulas) Common or Usual Name: Suction/Aspiration Cannulas Infusion/irrigation Cannulas Classification: Class II
Endoscope and accessories; 21 CFR 876.1500 Vacuum-powered suction apparatus; CFR 880.6740
III. PREDICATE DEVICES
The LySonix Suction/Aspiration Cannulas and Infusion Cannulas are substantially equivalent to suction and infusion cannula devices in commercial distribution by the following companies:
-
Ultra-Safe Ultrasonic Aspirator System (including suction cannulas); Morwel Corporation, Tucson, AZ; 510(k) number K962525
-
Suction Tips; Wells Johnson Company, Tucson, AZ; 510(k) number K832520
-
Endo-Pool Suction Cannulas and Irrigation Probes: Davol. Inc., Cranston, RJ: 510(k) numbers K914526 and 926479
-
Newman Cannulae System; Byron Medical Corporation, Tucson, AZ; 510(k) number K862936
-
Byron Suction Tips; Byron Medical Corporation, Tucson, AZ 510(k) number K861878
IV. DESCRIPTION
The LySonix Suction/Aspiration and Infusion Cannulas are hollow stainless steel tubes, with a blunt, bullet, or spatula-shaped tip. The cannulas are provided with an attached handle. The
1
Suction and Infusion Cannulas are each available in three cannula lengths and four diameters.
The LySonix Suction/Aspiration and Infusion Cannulas will be provided non-sterile
V. INTENDED USE
The LySonix Cannulas are instruments used for suction of fluids and tissue and for infusion of fluids during a variety of surgical procedures.
The LySonix Suction and Infusion Cannulas are inserted under the skin during various types of surgical procedures and may be connected to a suction or aspiration apparatus if desired. The Suction Cannula can then be used to suction out waste fluids or aspirate unwanted tissue. The Infusion Cannulas are used to infuse fluids such as medications or saline during surgery. The Suction/Aspiration and Infusion cannulas are not indicated for use with any specific surgical specialty, but are considered general surgical tools.
VI. TECHNOLOGICAL CHARACTERISTICS
The LySonix Suction and Infusion Cannulas have the same technological characteristics as their predicate devices.
The materials used in all the came. All the manufacturers of these cannulas provide the devices in stainless steel, a biocompatible metal. The handles of the LySonix cannulas are ahulminum, as are handles provided by the predicate devices.
No new technology is being introduced in the design of the LySonix Cannulas and the design of the cannulas is similar to the predicate Suction Aspiration Cannulas already on the market. The lengths and diameters of the LySonix Suction and Infusion Cannulas are within the same ranges as those of the predicate devices, and the choice of tip shapes and styles are the same standard designs as the choices provided by the predicate devices. The predicate devices provide for a variety of handles of the LySonix cannulas do not differ in technology or design. All the devices are provided non-sterile, with some of the predicate devices also being offered as a sterile option.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. M.J. Sarrasin, J.D. Vice President, Regulatory and Legal Affairs LySonix, Inc. 1170 Mark Avenue Carpinteria, California 93013
SEP 1 9 1997
Re: K972958
Trade Name: LySonix Suction/Aspiration and Infusion Cannulas Regulatory Class: I Product Code: FGY Dated: August 8, 1997 Received: August 11, 1997
Dear Mr. Sarrasin:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. M.J. Sarrasin, J.D.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement.
*For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: LYSONIX, INC.
510(k) Number (if known): N/A*
Device Name: LYSONIX SUCTION/ASPIRATION AND INFUSION CANNULAS
Indications For Use:
100
The LySonix Cannulas are instruments used for suction of thids and tissue and for infusion of fluids during a variety of surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Div. of General, Restorative and Neurological Devices) | |
|---|---|
| Division Sign-Off | |
| 510(k) Number | K972958 |
| Prescription Use
| Per 21 CFR 801.109 | ✓ | OR | Over-the-Counter |
|---|---|---|---|
| ---------------------------------------- | --- | ---- | ------------------ |