IMPACT MODEL 323 ASPIRATOR

K133196 · Impact Instrumentation, Inc. · JCX · Mar 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133196
• Device Name: IMPACT MODEL 323 ASPIRATOR
• Applicant: Impact Instrumentation, Inc.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Mar 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Self-contained, portable suction apparatus; removes debris, secretions, blood, vomitus, surgical fluids, tissue, and infectious materials from airway or wounds. Features vacuum gauge, adjustable vacuum regulator, 800 cc collection container, and rechargeable batteries; housed in injection-molded plastic case. Used in pre-hospital, hospital, mass casualty, and transport environments; operated by physicians or under physician order. Provides suction source for clinical airway management or wound care; assists in clearing obstructions or removing fluids to improve patient outcomes.

Clinical Evidence

Bench testing only. Device conforms to electrical safety and EMC requirements (IEC 60601-1, IEC 60601-1-2) and performance standards (EN ISO 10079-1).

Technological Characteristics

Powered suction pump; injection-molded plastic housing; vacuum gauge; adjustable vacuum regulator; 800 cc collection container; rechargeable battery-powered; portable form factor. Conforms to IEC 60601-1, IEC 60601-1-2, and EN ISO 10079-1.

Indications for Use

Indicated for patients requiring removal of airway/respiratory secretions, blood, vomitus, surgical fluids, tissue, or wound exudate. Suitable for pre-hospital, hospital, mass casualty, and transport settings. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Simex AC30 and DC30 (K061133)
• DeVilbiss 7305P (K982304)

Submission Summary (Full Text)

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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 Place<br>West Caldwell, NJ 07006 |
|----------|-----------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Alan Giordano - Regulatory Affairs Manager |

- 2. 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)
- 3. 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

- 4. 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:

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.

### 6. 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.

## 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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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(Division Sign-Off)

Division of Surgical Devices

510(k) Number: K133196

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