(93 days)
Not Found
No
The summary describes a mechanical device for delivering solutions and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is intended to deliver solutions onto a surgical site, which suggests it is an applicator/delivery system rather than a device that directly performs a therapeutic function. The statement about "Safety and effectiveness... demonstrated" and "substantially equivalent" further indicates its role as a delivery mechanism for therapies rather than a therapy itself.
No
Explanation: The device is intended to deliver solutions onto a surgical site, which is a therapeutic rather than a diagnostic function. There is no mention of it acquiring, analyzing, or interpreting data for diagnostic purposes.
No
The device description explicitly states it is a "Kit" consisting of "multi-lumen tubing" and relies on "filtered pressurized gas," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver two nonhomogenous solutions onto a surgical site." This describes a device used during a surgical procedure on a patient's body, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Device Description: The description of multi-lumen tubing for delivering solutions and gas aligns with a surgical delivery system, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests on samples, or providing diagnostic information based on laboratory analysis.
Therefore, the Air Assisted Sprayer is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Air Assisted Sprayer is intended to deliver two non-homogenous solutions onto a surgical site.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Air Assisted Sprayer Kit consists of multi-lumen tubing that provides separate channels for the flow of two non-homogeneous solutions and filtered pressurized gas.
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 effectiveness of the Air Assisted Sprayer have been demonstrated in this submission. The biocompatibility and in vitro bench testing data provided supports Confluent Surgical's belief that the Air Assisted Sprayer is substantially equivalent to the currently 510(k)-cleared MicroMedics Fibrijet Air Assisted Endoscopic Applicator.
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.
MicroMedics Fibrijet Air Assisted Endoscopic Applicator (K042834)
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
KOY 2322
NOV 1 4 2008
SECTION 5: 510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92.
| 510(k) Summary | August 12, 2008 |
|---|---|
| Date Prepared: | August 12, 2008 |
| Sponsor | Confluent Surgical, Inc. (Covidien) |
| 101A First Avenue | |
| Waltham, MA 02451 | |
| Contact | Virginia Vetter |
| Phone: (781) 839 1755 | |
| Fax: (781) 839 1763 | |
| E-mail: Virginia.Vetter@covidien.com | |
| Device Trade/Proprietary Name | Air Assisted Sprayer |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Class II | |
| Product Code: GCJ | |
| Common Name | Air Assisted Sprayer |
| Predicate Device(s) | MicroMedics Fibrijet Air Assisted Endoscopic |
| Applicator (K042834) | |
| DEVICE DESCRIPTION | |
| Product Description | The Air Assisted Sprayer Kit consists of multi-lumen |
| tubing that provides separate channels for the flow of two | |
| non-homogeneous solutions and filtered pressurized gas. | |
| Indications for Use | The Air Assisted Sprayer is intended to deliver two non- |
| homogenous solutions onto a surgical site. | |
| Safety and Effectiveness | Safety and effectiveness of the Air Assisted Sprayer have |
| been demonstrated in this submission. The | |
| biocompatibility and in vitro bench testing data provided | |
| supports Confluent Surgical's belief that the Air Assisted | |
| Sprayer is substantially equivalent to the currently | |
| 510(k)-cleared MicroMedics Fibrijet Air Assisted | |
| Endoscopic Applicator. | |
| Conclusion | Safety and effectiveness data, same indications for use |
| and same operating principle show the Air Assisted | |
| Sprayer to be substantially equivalent to a predicate |
CONFIDENTIAL
:
:
·
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Ms. Virginia Vetter Regulatory Affairs Specialist 101A First Avenue Waltham, Massachusetts 02451
NOV I 4 2008
Re: K082322
Trade/Device Name: Air Assisted Sprayer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopc and accessories Regulatory Class: II Product Code: GCJ Dated: November 7, 2008 Received: November 10, 2008
Dear Ms. Vetter:
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.
Image /page/1/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted with stylized lines, giving it a modern and symbolic appearance.
2
Page 2 - Ms. Virginia Vetter
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark H. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SECTION 4: INDICATIONS FOR USE STATEMENT
KO82322 510(k) Number (if known): Unknown
Device Name:
Air Assisted Sprayer
Indications for Use:
The Air Assisted Sprayer is intended to deliver two nonhomogenous solutions onto a surgical site.
Prescription Use X (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)
Neil R.Ryden for nxn
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082322
CONFIDENTIAL
Page 10 of 31
Confluent Surgical, Inc. (Covidien)