(226 days)
Not Found
No
The device description focuses on mechanical components and fluid control, with no mention of AI/ML terms or functionalities.
No
The device is used to deliver irrigation fluids and remove waste during surgery, but it does not directly treat a disease or medical condition.
No
The device is described as a suction and irrigation system used during laparoscopic surgical procedures to deliver fluids and remove debris. Its function is to facilitate the surgical process, not to diagnose conditions or diseases.
No
The device description clearly outlines physical components such as a handpiece, valves, a stainless steel probe, and connecting lines of tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering irrigation fluids and evacuating substances during laparoscopic surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a surgical tool used for irrigation and suction within the surgical field. It is designed to interact with the patient's internal environment during surgery.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. This device does not perform any such analysis on specimens.
The ASD-Tactile™ Suction and Irrigation System is a surgical instrument used in vivo (within the living body) during a procedure, not a device for in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
The ASD Tactile Suction and Irrigation System, SI-3000TY and SI-3000TY and SI-3000TYR, is indicated for use in patients undergoing general laparoscopic surgical procedures.
The ASD-Tactile™ Suction and Irrigation System is a sterile, single-use device indicated for use in patients undergoing general laparoscopic surgical procedures.
Product codes
GCJ
Device Description
It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site. The ASD Tactile Suction and Irrigation System consists of a handpiece equipped with 2 trumpet style valves, a stainless steel probe, and 2 connecting lines of tubing, one designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments, diameter sizes ranging from 2mm to 5mm to pass through without either a loss of pneumoperitoneum or leakage of fluid. A probe is attached to the handpiece via a threaded connector, thus allowing different sized probes to be attached to the handpiece during surgery.
The suction irrigator is a single use disposable device and is sold 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
9.0 COMPARISONS OF LEGALLY MARKETED DEVICES
510(k) SUMMARY
Page 1 of 1
- 7 2006
| 510(k) NUMBER: | K060182 |
|---|---|
| SUBMITTED BY: | Australian Surgical Devices Pty Ltd |
| 2/11 Ponderosa Parade | |
| Warriewood NSW 2102 AUSTRALIA | |
| 61-2-9979 4111 | |
| SEP | |
| CONTACT PERSON: | Mario Kuna |
| Chief Executive Officer | |
| DATE OF PREPARATION: | 17 July 2006 (amended) |
| NAME OF DEVICE: | Suction Irrigator |
| CLASSIFICATION NAME: | Laparoscope, General & Plastic Surgery |
| (Regulation Number 21CFR 876.1500, Endoscope | |
| and accessories). | |
| TRADE NAME: | ASD Tactile Suction and Irrigation System |
| PREDICATE DEVICE: | Applied Medical Resources Corporation, 22872 |
| Avenida Empresa, Rancho Santa margarita, CA- | |
| 92688 (K003443) | |
| SUMMARY STATEMENT: |
SUMMARY STATEMENT
The ASD Tactile Suction and Irrigation System, SI-3000TY and SI-3000TY and SI-3000TYR, is indicated for use in patients undergoing general laparoscopic surgical procedures. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site. The ASD Tactile Suction and Irrigation System consists of a handpiece equipped with 2 trumpet style valves, a stainless steel probe, and 2 connecting lines of tubing, one designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The handpiece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments, diameter sizes ranging from 2mm to 5mm to pass through without either a loss of pneumoperitoneum or leakage of fluid. A probe is attached to the handpiece via a threaded connector, thus allowing different sized probes to be attached to the handpiece during surgery.
The suction irrigator is a single use disposable device and is sold sterile.
The ASD Tactile Suction and Irrigation System, SI-3000TY and SI-3000TY and SI-3000TYR, is substantially equivalent to the Applied SI Suction irrigator, manufactured by Applied Medical Resources Corporation, 22872 Avenida Empresa, Rancho Santa Margarita, CA-92688. The ASD Suction and Irrigation System, SI-3000T, SI-3000TY and SI-3000TYR, is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2006
Australian Surgical Devices % Mr. Mario Kuna Chief Executive Officer 2/11 Ponderosa Parade Warriewood NSW 2102 Australia
Re: K060182
Trade/Device Name: ASD-Tactile™ Suction and Irrigation System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 7, 2006 Received: August 17, 2006
Dear Mr. Kuna:
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.
2
Page 2 - Mr. Mario Kuna
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) 276-0115. 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,
For Plobly
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K060182
Device Name:
ASD-Tactile™ Suction and Irrigation System
Indications for Use:
The ASD-Tactile™ Suction and Irrigation System is a sterile, single-use device indicated for use in patients undergoing general laparoscopic surgical procedures.
Prescription use: YES
AND/OR
Over-The-Counter Use: NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ploth
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 4-2
5100-) Number 060182