The IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for use in removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials from wounds, either during surgery or at the patient's bedside. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments. The Model 323 is only for use by or on the order of a physician.

Device Description

The IMPACT® Model 323 Aspirator is a completely self-contained suction source. It is lightweight, compact, easy to use and is easy to clean. It features a vacuum gauge, integral mounting hardware, power switch, rechargeable batteries, adjustable vacuum regulator, 800 cc collection container, integral carry handle, and convenient stowage of the container holders. The device is housed within an injection molded plastic case.

AI/ML Overview

The provided text describes a 510(k) submission for the IMPACT® Model 323 Aspirator, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with AI components or human-in-the-loop performance measurement. Therefore, much of the requested information regarding acceptance criteria derived from AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies, is not applicable to this document.

However, the document does specify performance criteria related to the device's functional integrity and safety.

Here's a breakdown of the information available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Electrical Safety	Conforms to IEC 60601-1 (3rd Edition - Corrigendum 2)	Conforms to IEC 60601-1 (3rd Edition - Corrigendum 2)
EMC Requirements	Conforms to IEC 60601-1-2:2007	Conforms to IEC 60601-1-2:2007
General Performance	Conforms to FDA's Guidance - "Guidance Document for Powered Suction Pump 510(k)s" (September 30, 1998)	Conforms to FDA's Guidance - "Guidance Document for Powered Suction Pump 510(k)s" (September 30, 1998)
Specific Performance	Conforms to EN ISO 10079-1:2009	Conforms to EN ISO 10079-1:2009
Human Factors/Usability	Conforms to FDA's Guidance on Human Factors and Usability Engineering	Conforms to FDA's Guidance on Human Factors and Usability Engineering

2. Sample size used for the test set and the data provenance

Not Applicable. This submission details the premarket notification for a physical medical device, not a software or AI-driven diagnostic/prognostic tool. The "test set" in this context refers to bench testing performed on the device itself, not a dataset of patient information for AI evaluation. The document does not specify the number of units tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of AI models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by its compliance with international standards and FDA guidance through bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically for resolving discrepancies in human expert labeling for AI training/testing, which is not relevant to this device's evaluation.

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. MRMC studies are used to evaluate diagnostic imaging systems, particularly in the context of AI assistance for human readers. This document is for a suction aspirator.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference for the device's performance is compliance with established international and national technical standards and regulatory guidance documents (e.g., IEC 60601-1, IEC 60601-1-2:2007, EN ISO 10079-1:2009, FDA Guidance for Powered Suction Pump 510(k)s, FDA Guidance on Human Factors and Usability Engineering). This compliance is typically verified through various forms of engineering and functional bench testing.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning product and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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MAR 1 0 2014

Impact Instrumentation Inc.

: -- -2 7 Fairfield Place, West Caldwell, NJ 0 7 0 0 6

510(k) Submission IMPACT® Model 323 Aspirator 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92.

1. Submitter's Name: Impact Instrumentation, Inc.

Address:	27 Fairfield PlaceWest Caldwell, NJ 07006
Phone:	(973) 882-1212
Fax:	(973) 882-4993
Contact:	Alan Giordano - Regulatory Affairs Manager

1. Device Name: IMPACT® Model 323 Aspirator Trade Name: Model No.: 701-0323-01 (Aspirator Unit Only) 800-0323-00 (Aspirator w/Accessories) Common Name: Aspirator Classification Name: Powered Suction Pump (21 CFR 878.4780)
1. Device Class:

The IMPACT® Model 323 Aspirator has been classified as:

Requiatory Class: II Panel: General and Plastic Surgery Devices Product Code: JCX (Apparatus, suction, ward use, portable, ac-powered) Registration Number: 2242630

1. Predicate Device: The predicate device is the:
- Simex AC30 and DC30 (K061133) marketed by . NovaSpine LLC.
- DeVilbiss 7305P (K982304) marketed by DeVilbiss . Healthcare LLC.

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Impact Instrumentation Inc.

2 7 Fairfield Place, West Caldwell, NJ 0 7 0 0 6

5. Intended Use:

6. Device Description:

7. Performance Summary:

The IMPACT® Model 323 Aspirator conforms to the Electrical Safety and EMC requirements in IEC 60601-1 (30 Edition - Corrigendum 2) and IEC 60601-1-2:2007. It also conforms to the performance requirements outlined in FDA's Guidance - Guidance Document for Powered Suction Pump 510(k)s (September 30, 1998), EN ISO 10079-1:2009 and FDA's Guidance on Human Factors and Usability Engineering.

8. Conclusions:

The IMPACT® Model 323 Aspirator, (Model 701-0323-01) . has the same intended use and similar technological characteristics as the Simex AC30 and DC30 (K061133) marketed by NovaSpine LLC and DeVilbiss 7305P (K982304) marketed by DeVilbiss Healthcare LLC.
Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the IMPACT® Model 323 Aspirator is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2014

Impact Instrumentation Incorporated Mr. Alan Giordano Regulatory Affairs Manager 27 Fairfield Place West Caldwell, New Jersey 07006

Re: K133196

Trade/Device Name: IMPACT® Model 323 Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: February 11, 2014 Received: February 14, 2014

Dear Mr. Giordano:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Alan Giordano

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Impact Instrumentation Inc.

2 7 Fairfield Place, West Coldwell, NJ 07006

510(k) Submission IMPACT® Model 323 Aspirator Indications for Use

510(k) Number (if known): K133196

Device Name: IMPACT® Model 323 Aspirator

Indications For Use:

AND/OR Over-The-Counter Use × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Date: 2014-03-10 08:11:27 Chen -A -:

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(Division Sign-Off)

Division of Surgical Devices

510(k) Number: K133196

Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.