(93 days)
The Air Assisted Sprayer is intended to deliver two nonhomogenous solutions onto a surgical site.
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.
The provided 510(k) summary for the KOY 2322 Air Assisted Sprayer does not contain the specific information requested about acceptance criteria or a detailed study proving the device meets those criteria, as it is primarily a substantial equivalence claim based on predicate device comparison.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (MicroMedics Fibrijet Air Assisted Endoscopic Applicator, K042834) rather than presenting a study against a pre-defined set of acceptance criteria for novel device performance. The safety and effectiveness are stated to be demonstrated through biocompatibility and in vitro bench testing, but the details of these tests, including specific acceptance criteria and results, are not provided in the publicly available summary.
Therefore, for almost all of your requested information, the answer will be "Not directly addressed in the provided 510(k) summary."
Below is an attempt to answer your questions based only on the provided text, highlighting where information is absent:
Acceptance Criteria and Device Performance Study for KOY 2322 Air Assisted Sprayer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (The 510(k) summary states that "biocompatibility and in vitro bench testing data provided supports Confluent Surgical's belief that the Air Assisted Sprayer is substantially equivalent..." However, no specific acceptance criteria for these tests or their quantitative results are provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in the provided summary.
- Data Provenance: Not specified beyond "biocompatibility and in vitro bench testing data." The origin (e.g., country) or nature (retrospective/prospective) of this data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The summary does not describe a clinical study involving human judgment for "ground truth" establishment. The evaluation mentioned is primarily in vitro bench testing.
4. Adjudication method for the test set
- Not Applicable. No human adjudication of results is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device. No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithmic device. The device is a physical sprayer. The in vitro bench testing mentioned would be analogous to a standalone performance evaluation for a physical device, but the specifics are not detailed.
7. The type of ground truth used
- Not explicitly stated in terms of "ground truth" for a performance study. The summary refers to "biocompatibility and in vitro bench testing data." For these types of tests, the "ground truth" would typically be established by established scientific standards, laboratory measurements, or material properties and biological responses, rather than expert consensus or pathology in the context of imaging.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that involves training sets.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
{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 AvenueWaltham, MA 02451 |
| Contact | Virginia VetterPhone: (781) 839 1755Fax: (781) 839 1763E-mail: Virginia.Vetter@covidien.com |
| Device Trade/Proprietary Name | Air Assisted Sprayer |
| Classification Name | Laparoscope, General & Plastic SurgeryClass IIProduct Code: GCJ |
| Common Name | Air Assisted Sprayer |
| Predicate Device(s) | MicroMedics Fibrijet Air Assisted EndoscopicApplicator (K042834) |
| DEVICE DESCRIPTION | |
| Product Description | The Air Assisted Sprayer Kit consists of multi-lumentubing that provides separate channels for the flow of twonon-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 havebeen demonstrated in this submission. Thebiocompatibility and in vitro bench testing data providedsupports Confluent Surgical's belief that the Air AssistedSprayer is substantially equivalent to the currently510(k)-cleared MicroMedics Fibrijet Air AssistedEndoscopic Applicator. |
| Conclusion | Safety and effectiveness data, same indications for useand same operating principle show the Air AssistedSprayer to be substantially equivalent to a predicate |
CONFIDENTIAL
:
:
·
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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.
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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
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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)
§ 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.