NovoPore™ is intended to be used as part of a Negative Pressure Wound Therapy (NPWT) system. When used in conjunction with a NPWT system, it is intended to remove excess exudate, infectious material, and tissue debris from wounds which may promote wound healing. NPWT systems are indicated for use on chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), explored fistulas, flaps, and grafts.

Device Description

The NovoPore™ Dressing is a polyurethane foam wound dressing used as an accessory to powered suction pumps. The single-use dressing is packaged in a peelable oriented polyamide / polyethylene bag and is sterilized by gamma irradiation. The NovoPore™ Dressing is available in one size: medium.

AI/ML Overview

The NovoPore™ Dressing is a polyurethane foam wound dressing intended for use with Negative Pressure Wound Therapy (NPWT) systems. The study provided focuses on establishing substantial equivalence to predicate devices (KCI GranuFoam® and Genadyne A4-XLR8 Foam Dressing) through non-clinical performance data and does not involve human clinical trials for efficacy or effectiveness.

Here’s a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by demonstrating performance that is "substantially equivalent" or comparable to the predicate devices. For mechanical properties, the device aimed to show similar or better performance compared to the predicates.

Acceptance Criteria (Implied by Predicate Equivalence)	NovoPore™ Dressing Performance	Predicate (GranuFoam™) Performance	Predicate (A4-XLR8 Foam) Performance
Material Composition
Dressing Composition	Porous, open-celled polyurethane foam	Porous, open-celled polyurethane foam	Porous, open-celled polyurethane foam
Material	Polyurethane	Polyurethane	Polyurethane
Physical Characteristics
Form	Foam	Foam	Foam
Method to achieve Open-Celled Foam	Crushing the foam	Reticulating the foam	Reticulating the foam
Color	White	Black	Green
Dimensions (medium), cm	18 x 12.5 x 3	18 x 12.5 x 3.2	18 x 12.5 x 3.3
Foam Density	66.1 kg/m³	23.0 kg/m³	21.1 kg/m³
Open Pore Size	100 - 600 microns	400 - 600 microns	Not available
Mechanical Properties Under Pressure (Wet)
Cyclic Compression - Mean Upper Compressive Stress (0 min)	20.7 ± 3.2 kPa	13.4 ± 0.4 kPa	12.8 ± 1.3 kPa
Cyclic Compression - Mean Upper Compressive Stress (1 hr)	21.4 ± 3.4 kPa	12.5 ± 0.6 kPa	11.5 ± 0.9 kPa
Cyclic Compression - Mean Upper Compressive Stress (2 hrs)	20.3 ± 3.4 kPa	12.8 ± 0.9 kPa	11.6 ± 0.9 kPa
Cyclic Compression - Mean Upper Compressive Stress (4 hrs)	18.0 ± 2.7 kPa	13.4 ± 1.0 kPa	12.0 ± 1.0 kPa
Cyclic Compression - Mean Upper Compressive Stress (6 hrs)	17.2 ± 2.3 kPa	13.9 ± 1.1 kPa	12.6 ± 1.2 kPa
Resilience Change (0 min)	0.0 ± 0 %	0.0 ± 0 %	0.0 ± 0 %
Resilience Change (1 hr)	2.0 ± 0 %	8.9 ± 1.6 %	10.3 ± 1.2 %
Resilience Change (2 hrs)	2.0 ± 0 %	10.3 ± 1.6 %	11.9 ± 1.4 %
Resilience Change (4 hrs)	2.0 ± 0 %	12.3 ± 2.1 %	14.4 ± 2.1 %
Resilience Change (6 hrs)	2.0 ± 0 %	14.2 ± 2.2 %	16.7 ± 3.1 %
Mean Change in Thickness after 6 hours (1350 cycles)	Decrease by avg of 1.5 ± 0.5%	Decrease by avg of 7.6 ± 2.6%	Decrease by avg of 8.0 ± 2.4%
Durability after 1350 compressive cycles, wet	No Damage	No Damage	No Damage
Vacuum Bench Test
Pressure Distribution	Evenly Distributed at each time point	Evenly Distributed at each time point	Not Tested
Fluid Flow (at T=0, 24h, 48h, 72h)	25 ml fluid drawn through within 30 seconds at every time point	25 ml fluid drawn through within 30 seconds at every time point	Not Tested
Dimensional change after 72h	<10% change in dimensions	<10% change in dimensions	Not Tested
Material Strength
Tensile Strength	223 ± 17 kPa	105 ± 13 kPa	Not Tested
Tensile Elongation at Break	225 ± 11 %	185 ± 24 %	Not Tested
Tear Strength	399 ± 32	733 ± 76	Not Tested
Sterilization & Shelf-Life
Single-Use	Yes	Yes	Yes
Supplied Sterile	Yes	Yes	Yes
Sterilization Method	Gamma Irradiation	Gamma Irradiation	EO
Shelf Life	Two (2) years	Three (3) years	Three (3) years

Study Proving Acceptance Criteria:

The study used to prove the device met acceptance criteria was a non-clinical bench testing program comparing the NovoPore™ Dressing to two legally marketed predicate devices: KCI GranuFoam™ and Genadyne A4-XLR8 Foam Dressing. The submission uses the term "substantially similar performance" and "met all acceptance criteria" for the mechanical and vacuum tests. The acceptance criteria were implicitly defined by the performance characteristics of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific non-clinical mechanical test. However, results are provided with standard deviations (e.g., 20.7 ± 3.2 kPa), indicating that multiple samples were tested for each measurement.
Data Provenance: The data is "retrospective" in the sense that it's laboratory bench test data collected by the manufacturer to support a 510(k) submission. The country of origin of the data is the location where the testing was performed, which is implied to be Australia, given the submission sponsor's location (PolyNovo Biomaterials Pty Ltd, Victoria Australia).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. The study is a non-clinical bench test. "Ground truth" in this context refers to the measured physical and mechanical properties of the devices, not expert interpretations.

4. Adjudication Method for the Test Set

This is not applicable. The study involved objective measurements of physical and mechanical properties, not subjective expert assessment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This was a non-clinical bench effectiveness study, not an MRMC comparative effectiveness study involving human readers or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device (wound dressing), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" was based on objective, quantitative measurements of physical and mechanical properties (e.g., compressive stress, resilience, fluid flow, tensile strength, density) of the NovoPore™ Dressing and the predicate devices. These measurements are considered the 'truth' of the device's performance characteristics.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

510(k) Summary

for

NovoPore™ Dressing

1. Submission Sponsor

PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne, 3207 Victoria Australia Phone: 613 8681 4086 Fax: 613 8681 5099 Contact: Dr. Tim Moore, Principal Scientist

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

February 25, 2014

4. Device Identification

Trade/Proprietary Name:	NovoPore™ Dressing
Common/Usual Name:	Negative Pressure Wound Therapy Foam
Classification Name:	Negative Pressure Wound Therapy Powered Suction Pump andAccessories
Classification Regulation:	878.4780
Product Code:	OMP
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device(s)

Kinetic Concepts, Inc. (KCI) GranuFoam®, 510 (k) Number K032310 Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing, 510 (k) Number K092992

{1}------------------------------------------------

6. Device Description

The NovoPore™ Dressing is available in one size: medium.

7. Indication for Use Statement

8. Substantial Equivalence Discussion

The following table compares the NovoPore™ Dressing device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Device Manufacturer	PolyNovo Biomaterials	THET BLEKinetic Concepts, Inc.	Genadyne
	Pty Ltd	(KCI)	Blotechnologies, Inc.
		GranuFoam™
Device Trade Name	NovoPore™ Dressing		A4-XLR8 Foam
			Dressing
510(k) Number	K132936	K032310	K092992
Regulation Number	878.4780	878.4780878.4780
Product Code	OMP	OMPOMP
Common/Usual Name	Negative Pressure Wound	Negative Pressure Wound	Negative Pressure Wound
	Therapy Foam	Therapy Foam	Therapy Foam
Regulation Name	Negative Pressure Wound	Negative Pressure Wound	Negative Pressure Wound
	Therapy Powered Suction	Therapy Powered Suction	Therapy Powered Suction
	Pump and Accessories	Pump and Accessories	Pump and Accessories
Indications for Use	NovoPore™ is intended to	The V.A.C.® family of	Genadyne A4-XLR8 Foam
	be used as part of a	devices are feedback-	Dressing is intended to be
	Negative Pressure Wound	controlled negative	used In conjunction with
	Therapy (NPWT) system.	pressure devices used to	the Genadyne A4 Wound
	When used in conjunction	help promote wound	Vacuum System
	with a NPWT system, it is	healing, through means	(K082676) to deliver
	intended to remove	Including vacuum assisted	negative pressure wound
	excess exudate, infectious	drainage and removal of	therapy to the wound.
	material, and tissue debris	infectious material or	Genadyne A4 Wound
	from wounds which may	other fluids, under the	Vacuum System is
	promote wound healing.	influence of continuous	indicated for patients who
	NPWT systems are	and/or intermittent	would benefit from a
	indicated for use on	suction pressures,	suction device,
	chronic, acute, traumatic,	particularly for patients	particularly as the device
	subacute and dehisced	with chronic, acute,	may promote wound
	wounds, partial-thickness	traumatic, subacute and	healing by the removal of

Table 5A - Comparison of Characteristics

{2}------------------------------------------------

Device Manufacturer	PolyNovo BiomaterialsPty Ltd	Kinetic Concepts, Inc.(KCI)	GenadyneBiotechnologies, Inc.
Device Trade Name	NovoPore™ Dressing	GranuFoam™	A4-XLR8 Foam
			Dressing
	burns, ulcers (such asdiabetic or pressure),explored fistulas, flaps,and grafts.	dehisced wounds, partial-thickness burns, ulcers(such as diabetic orpressure), flaps andgrafts. Feedback control isachieved by measuringthe level of negativepressure at the woundsite.	excess exudates,infectious material andtissue debris.A4-XLR8 Foam Dressing isappropriate for use on thefollowing wounds:• Pressure ulcers• Diabetic/Neuropathic Ulcers• Venous insufficiencyulcers• Traumatic wounds• Post-operative anddehisced surgicalwounds• Comparative BenchCaution: Federal lawrestricts this device to saleby or on the order of a
			physician.
Dressing Composition	Porous, open-celledpolyurethane foam	Porous, open-celledpolyurethane foam	Porous, open-celledpolyurethane foam
Form	Foam	Foam	Foam
Material	Polyurethane	Polyurethane	Polyurethane
Method to achieve	Crushing the foam	Reticulating the foam	Reticulating the foam
Open-Celled Foam
Color	White	Black	Green
Dimensions (medium),cm	18 × 12.5 × 3	18 × 12.5 × 3.2	18 × 12.5 × 3.3
Recommended	-50 to -175	-125 plus or minus	-50 to -230
pressure range		increments of 25-75 as
(mmHg)		needed, up to -250.
Cyclic compression -	0 min: 20.7±3.2 kPa	0 min: 13.4±0.4kPa	0 min: 12.8±1.3 kPa
Mean Upper	1 hr: 21.4 ±3.4 kPa	1 hr: 12.5 ±0.6 kPa	1 hr: 11.5 ±0.9 kPa
Compressive Stressand Standard	2 hrs: 20.3±3.4 kPa	2 hrs: 12.8±0.9 kPa	2 hrs: 11.6±0.9 kPa
deviation at 0, 1, 2, 4	4 hrs: 18.0 ± 2.7 kPa	4 hrs: 13.4 ± 1.0 kPa	4 hrs: 12.0 ± 1.0 kPa
and 6 hours, wet	6 hrs: 17.2±2.3 kPa	6 hrs: 13.9 ±1.1 kPa	6 hrs: 12.6± 1.2 kPa
Cyclic compression -	0 min: 0.0±0 %	0 min: 0.0± 0 %	0 min: 0.0± 0 %
Resillence change at 0,	1 hr: 2.0 ± 0 %	1 hr: 8.9 ±1.6 %	1 hr: 10.3 ± 1.2 %
1, 2, 4, and 6 hours,wet	2 hrs: 2.0±0 %	2 hrs: 10.3± 1.6 %	2 hrs: 11.9 ± 1.4 %
	4 hrs: 2.0± 0 %	4 hrs: 12.3 ± 2.1 %	4 hrs: 14.4 ± 2.1 %
	6 hrs: 2.0± 0 %	6 hrs: 14.2 ± 2.2 %	6 hrs: 16.7± 3.1 %
Mean Change inThickness after 6hours, wet (1350cycles)	Decrease by an average of1.5 ± 0.5%	Decrease by an average of7.6 ± 2.6%	Decrease by an average of8.0 ± 2.4%

・

{3}------------------------------------------------

Device Manufacturer	PolyNovo BlomaterialsPty Ltd	Kinetic Concepts, Inc.(KCI)	GenadyneBiotechnologies; Inc.
Device Trade Name	NovoPore™ Dressing	GranuFoam™	A4-XLR8 FoamDressing
Durability after 1350compressive cycles,wet	No Damage	No Damage	No Damage
Vacuum Bench Test -Pressure distribution	Evenly Distributed at eachtime point	Evenly Distributed at eachtime point	Not Tested
Vacuum Bench Test -Fluid Flow (T=0, 24h,48h, 72h)	25 ml fluid drawn throughwithin 30 seconds atevery time point	25 ml fluid drawn throughwithin 30 seconds atevery time point	Not Tested
Vacuum Bench Test -Dimensional changeafter 72h	<10% change indimensions	<10% change in- dimensions	Not Tested
Tensile Strength	$223 \pm 17$ kPa	$105 \pm 13$ kPa	Not Tested
Tensile Elongation atBreak	$225 \pm 11$ %	$185 \pm 24$	Not Tested
Tear Strength	$399 \pm 32$	$733 \pm 76$	Not Tested
Foam Density	66.1 kg/m³	23.0 kg/m³	21.1 kg/m³
Open Pore Size	100 - 600 microns	400 - 600 microns	Not available
Single-Use	Yes	Yes	Yes
Supplied Sterile	Yes	Yes	Yes
Sterilization Method	Gamma Irradiation	Gamma Irradiation	EO
Shelf Life	Two (2) years	Three (3) years	Three (3) years

9. Non-Clinical Performance Data

Mechanical properties of NovoPore™ Dressing were evaluated and compared with the predicates V.A.C. GranuFoam™ Dressing and A4-XLR8 Foam Dressing. The following testing has been performed to support substantial equivalence:

. Biocompatibility - Biocompatibility testing of the NovoPore™ Dressing was conducted in accordance with the ISO 10993-1 "Biological evaluation of medical devices" standards and FDA/CDRH/ODE Blue Book Memorandum G95-1, "Use of International Standard ISO 10993", 'Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing' using a representative device. Based on ISO 10993-1, NovoPore™ Dressing is intended for use in direct contact with wounds, and the finished device is used in the human body for 24 (twenty-four) hours to 30 (thirty) days. The NovoPore™ Dressing was tested for Cytotoxicity per ISO 10993-5: Mutagenicity (In Vitro Mouse Lymphoma Assay) per ISO 10993-3; Bacterial Reverse Mutation (AMES test) per ISO 10993-3; Intracutaneous Reactivity, Skin Sensitisation (polar and non-polar) per ISO 10993-1, ISO 10993-10, and ISO 10993-12; per ISO 10993-1; Subcutaneous implantation per ISO 10993-1, ISO 10993-6, and ISO 10993-12; and Pyrogenicity per Ph. Eur. 7th edition. The results for the biocompatibility testing showed that there are no negative impacts from materials that are used in the NovoPore™ Dressing.
. Shelf-life - Stability of the subject device was established from the results of physical testing data using a protocol. Based on the evaluation of the results of the physical

{4}------------------------------------------------

testing data, the expiring date has been set at two (2) years in accordance with ISO 11607 and ASTM F1980-07.

Package Stability Based on the results, these tests confirm the sealing and seal system . (selection of materials) of the tested packages are suitable to maintain the integrity and therefore the microbial barrier of packages for medical devices as required by ISO 11607-1. LAL testing is routinely used to verify acceptable low levels of endotoxin contamination per AAMI ST72.
. Mechanical testing -The tests involved cyclic compressive stress at various time points, resilience under cyclic compressive testing, durability under accelerated cyclic compression, and performance under vacuum, testing. It was concluded that the NovoPore™ Dressings met all acceptance criterion for Mean USC, Mean SZL, and Mean percentage Change in Thickness, and degree of damage, hence are substantially equivalent to GranuFoam™ and XLR8 in terms of cyclic mechanical properties. It was also concluded that the NovoPore™ dressings showing substantially similar performance to GranuFoam dressings during and after the 72 hours of 17 kPa vacuum non-clinical bench testing.
. Risk Management – Risk Analysis was conducted according to ISO 14971, and the outcomes of these risks are considered acceptable, and that all potential risks have been mitigated to the lowest form.

As part of demonstrating safety and effectiveness of NovoPore™ Dressing and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, PolyNovo Biomaterials Pty Ltd completed a number of tests. The NovoPore™ Dressing meets all the requirements for overall design, sterilization, and biocompatibility confirms that the output meets the design inputs and specifications. The NovoPore™ Dressing passed all testing stated above as shown by the acceptable results obtained.

The NovoPore™ Dressing complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

10. Clinical Performance Data

Human clinical trials are not applicable as there are no new innovative aspects that have been introduced. These types of products have been on the market for many years with no significant incidents of safety or efficacy for the predicate devices. The design, development and testing of the NovoPore™ Dressing has not resulted in the need for any clinical trials.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the

{5}------------------------------------------------

predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the difference between the NovoPore™ Dressing and the predicate devices do not raise any questions regarding its safety and effectiveness. The NovoPore™ Dressing, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

{6}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.

Public Health Service

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

March 4, 2014

PolyNovo Biomaterials Pty Ltd % Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K132936

Trade/Device Name: NovoPore Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: January 30, 2014 Received: January 31, 2014

Dear Ms. Hetrick:

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. Ilsting 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

{7}------------------------------------------------

Page 2 - Ms. Carrie Hetrick

device-related adverse events) (21 CFR 803); 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.

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,

David Krause -S

for

、

Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132936

Device Name NovoPore™ Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Recreation Use (21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart G)
-----------------------------------------------------	-----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

Please do not write below this line - continue on a separate page if needed.

FOR FDA USE ONLY 1 4 2011 11:21 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

David K

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.