The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.

Device Description

The VOLTERA Powered Suction Pump, S1001-3 Series is a lightweight, suction device intended for wound management via application of continual or intermittent negative pressure wound therapy to the wound for removal of fluids, including wound exudates, irrigation fluids, and infectious materials. The pump is connected to the wound dressing via a tube connected to a disposable canister. The device provides negative pressure wound therapy to the wound at a range of pressure settings and removes exudates from the wound site to the disposable canister. The device can operate either by a mains power supply or internal battery.

AI/ML Overview

The provided text describes a 510(k) submission for the VOLTERA Powered Suction Pump S1001-3 Series. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, not on a study proving the device meets specific acceptance criteria in a clinical setting with human-in-the-loop performance.

Here's an analysis of the provided information relative to your request:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed reported performance alongside those criteria in a table format. Instead, it states that "All the test results demonstrate the performance of VOLTERA Powered Suction Pump meets the requirements of its pre-defined acceptance criteria and intended uses." This implies that the device successfully met internal criteria for various tests.

However, the "Substantial Equivalence Determination" section (excerpt 2) provides a comparison chart of specifications between the proposed device and two predicate devices. While not "acceptance criteria" in the traditional sense of a clinical study, these specifications serve as performance benchmarks for demonstrating equivalence.

Item	Acceptance Criteria (Predicate Device K062456 / K112458)	Reported Device Performance (VOLTERA S1001-3 Series)
Intended Use	Similar scope for wound management, fluid removal, and promotion of healing.	Matched
Indications for Use	Management of chronic, acute, traumatic, sub-acute, dehisced wounds, partial thickness burns, ulcers (diabetic, pressure), flaps and grafts.	Matched
Contraindications	Similar list including necrotic tissue, unexplored fistulas, untreated osteomyelitis, malignancy, exposed arteries/veins/organs.	Similar list (minor variations in wording).
Maximum Vacuum	-200 mmHg	-200 mmHg
Noise	35 dba	30dba at 190 cm
Weight	2.8 kg (PRO-I), 1.8~2.8 kg (PRO-I, PRO-II, PRO-III)	1.35 kg
Voltage	100-240V / 50-60Hz	100-240V / 50-60Hz
Operation	Continuous and Intermittent	Continuous and Intermittent
Battery Operation	24~48hrs depending on use	24~48hrs depending on use
Consumable/Disposable components	Collection canister, related hoses, hose connectors, filters, other accessories.	Matched
Suction	9 liters/min	2.5 liters/min
Dimensions	290359130 mm	17016090 mm

Note on "Acceptance Criteria" for Medical Devices: For 510(k) submissions, "acceptance criteria" often refer to the successful completion of specific predefined non-clinical tests (e.g., electrical safety, electromagnetic compatibility, risk management, mechanical performance) to demonstrate that the device performs as intended and is as safe and effective as a legally marketed predicate device. The document explicitly states these types of tests were performed and met requirements.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text does not mention a "test set" in the context of clinical data for performance evaluation. The testing described is "in vitro and in vivo preclinical physical and mechanical tests." These are likely engineering and lab tests, not clinical studies with human subjects. Therefore, sample size and data provenance in terms of human subjects are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. Given the nature of the non-clinical testing described, the "ground truth" would be established by technical specifications, established test methods, and industry standards, rather than expert clinical consensus on images or outcomes.

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

Not applicable, as no clinical test set with human subject data and expert adjudication 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 device is a powered suction pump, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

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

The device is a physical powered suction pump. The concept of "standalone algorithm performance" (without human-in-the-loop) typically applies to software or AI-driven devices. While the pump operates independently (standalone in a functional sense), this question is usually framed in the context of AI/software. If interpreting "standalone performance" as the device operating independently without constant human intervention, then yes, the pump is designed to operate in a standalone manner to apply negative pressure. However, this is not performance of an algorithm.

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

The "ground truth" for the non-clinical tests would be defined by the specifications and performance standards set by relevant international standards (IEC 60601-1-1, IEC 60601-1-2, ISO 14971:2007) and the performance of the predicate devices. For example, if a test was to measure maximum vacuum, the "ground truth" would be the required -200 mmHg, and the device's output would be compared against that.

8. The sample size for the training set:

Not applicable. This submission concerns a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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

VOLTERA Powered Suction Pump S1001-3 Series

NOV 9 2012

510(k) Summary

న. 1 Type of Submission: 、Traditional
5.2 Preparation Date: Jul 7, 2011
5.3 Revised Date: August 1, 2012

5.4 Submitter:	Carilex Medical, Inc.
Address:	No.77, keji 1st Road, Guishan Township, Taoyuan County333, Taiwan, R.O.C.
Phone:	+886-03-3287882
Fax:	+886-03-3288622
Contact:	Clytie Chiou

Establishment Registration Number: 9710603

5.3 Identification of the Device:

Proprietary/Trade name:	VOLTERA Powered Suction Pump, S1001-3 Series
Common Name:	Powered Suction Pump
Classification Name:	Negative Pressure Wound Therapy Powered Suction
	Pump
Device Classification:	II
Regulation Number:	878.4780
Panel:	General & Plastic Surgery
Product Code:	OMP

5.4 Identification of the Predicate Device:

Predicate Device Name:	NovaSpine Powered Suction Pump PRO-I
Manufacturer:	NovaSpine LLC
510(k) Number or Clearance Information:	K062456
Predicate Device Name:	Prospera PRO-I, PRO-II and PRO-III Negative

Pressure Wound Therapy System

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

VOLTERA Powered Suction Pump S1001-3 Series

Manufacturer: Medica-Rents Co LTD 510(k) Number or Clearance Information: K112458

5.5 Intended Use and Indications for Use of the subject device.

The VOLTERA Powered Suction Pump, S1001-3 Series is indicated for patients who would · benefit from wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris which may promote wound healing. The VOLTERA Powered Suction Pump is indicated for removal of exudate from traumatic, dehisced wounds, partial thickness burns, chronic wounds such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, acute wounds, and flaps and grafts.

5.6 Device Description

5.7 Non-clinical Testing

A series of in vitro and in vivo preclinical physical and mechanical tests were performed to assess the safety and effectiveness of the VOLTERA Powered Suction Pump. The tests were conducted in accordance with IEC 60601-1-1 Safety Requirements for Medical Electrical Systems (06/92), Am.1 (11/95), Ed.2 (12/00), IEC 60601-1-2 Electromagnetic Compatibility - Requirements and Tests (04/93), Ed.2 (09/01), Am.1 (09/04), Ed. 2.1 (11/04), ISO 14971:2007 Medical devices- Application of risk management to medical devices. All the test results demonstrate the performance of VOLTERA Powered Suction Pump meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the VOLTERA Powered Suction Pump is substantially equivalent to the predicate devices.

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

5.8 Substantial Equivalence Determination

The VOLTERA Powered Suction Pump submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared NovaSpine Powered Suction Pump PRO-I which is the subject of K062456 and Prospera PRO-I, PRO-II and PRO-III Negative Pressure Wound Therapy System which is the subject of K 112458. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Proposed Device(VOLTERA PoweredSuction Pump,S1001-3 Series)	Predicate Device(NovaSpine PoweredSuction Pump PRO-I,K062456)	Predicate Device(Prospera PRO-I,PRO-II and PRO-IIINegative PressureWound TherapySystem, K112458)
Classification	Class II	Class II	Class II
Code or FederalRegulations	878.4780	878.4780	878.4780
PrescriptionMedical Devices	YES	YES	YES
Intended Use	The VOLTERAPowered SuctionPump, S1001-3 Seriesis indicated for patientswho would benefitfrom woundmanagement via theapplication of negativepressure for removal offluids and excess	The NovaSpinePowered Suction PumpPROMI is indicatedfor patients who wouldbenefit from a suctiondevice particularly asthe device maypromote woundhealing or for theaspiration and removal	The Prospera NegativePressure WoundTherapy System isindicated for patientsthat would benefitfrom a suction deviceparticularly as thedevice may promotewound healing byremoval of wound
	exudate, infectiousmaterial, and tissuedebris which maypromote woundhealing. TheVOLTERA PoweredSuction Pump isindicated for removalof exudate fromtraumatic, dehiscedwounds, partialthickness burns,chronic wounds suchas pressure ulcers,diabetic foot ulcers,venous leg ulcers,acute wounds, andflaps and grafts.	of surgical fluids,tissue (includingbone), gases, bodilyfluids or infectiousmaterials from apatient's airway orrespiratory supportsystem either duringsurgery or at thepatient's bedside.	exudate, debris, andinfectious material orfor the aspiration andremoval of surgicalfluids, tissue(including bone),gases, bodily fluids orinfectious materialfrom the patient'sairway or respiratorysupport system. TheProspera NegativePressure WoundTherapy may be usedduring surgery or at thepatient's bedside and isindicated for home use.
Model	S1001-3 Series	PRO-I	PRO-I, PRO-II,PRO-III
IndicationsforUse	The Voltera suctionpump is indicated onuse with patients withthe following wounds:> Traumatic> Dehisced wounds> Partial thicknessburns (theepidermis andsome portion ofthe dermis havebeen burned or	For management ofchronic, acute,traumatic, sub acuteand dehisced wounds,partial thickness burns,ulcers (such as diabeticor pressure), flaps andgrafts.	For management ofchronic, acute,traumatic, sub acuteand dehisced wounds,partial thickness burns,ulcers (such as diabeticor pressure), flaps andgrafts.
	injured)
	Chronic wounds
	(pressure
	ulcers,diabetic
	foot ulcers, venous
	leg ulcers)
	Acute wounds
	Traumatic
	Flaps and grafts
Contraindications	Contraindicated forpatients with thefollowing conditions:1. Presence ofnecrotic tissue2. Malignancy3. UntreatedOsteomyelitis4. Untreatedmalnutrition5. Exposed arteries,veins, nerves, ororgans6. Use overanastomotic sites	The PRO-I iscontraindicated in thepresence of:1. Necrotic tissue2. Unexplored ornon-entericfistulas3. Untreatedosteomyelitis4. Malignancy in thewound5. Exposed arteries,veins, or organs	The PRO-I, PRO-II,PRO-III iscontraindicated in thepresence of:1. Necrotic tissue2. Unexplored ornon-entericfistulas3. Untreatedosteomyelitis4. Malignancy in thewound5. Exposed arteries,veins, or organs
Specification	Suction: 2.5 liters/min	Suction: 9 liters/min	Suction: 9 liters/min
	Maximum Vacuum:-200 mmHg	Maximum Vacuum:-200 mmHg	Maximum Vacuum:-200 mmHg
	Noise: 30dba at 190cm	Noise: 35 dba	Noise: 35 dba
	Weight: 1.35 kg	Weight: 2.8 kg	Weight: 1.8~2.8 kg
	Voltage: 100-240V /	Voltage: 100-240V /	Voltage: 100-240V /
	50-60Hz	50-60Hz	50-60Hz
	Operation: Continuous	Operation: Continuous	Operation: Continuous
	and Intermittent	and Intermittent	and Intermittent
	Battery Operation:	Battery Operation:	Battery Operation:
	24~48hrs depending	24~48hrs depending	24~48hrs depending
	on use	on use	on use
	Dimensions:	Dimensions:	Dimensions:
	17016090 mm	290359130 mm	290359130 mm
Consumable/Disposablecomponents	Collection canister(secretion container)	Collection canister(secretion container)	Collection canister(secretion container)
	Related hoses (tubing)	Related hoses (tubing)	Related hoses (tubing)
	Hose connectors	Hose connectors	Hose connectors
	Filters	Filters	Filters
	Other accessories	Other accessories	Other accessories

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

VOLTERA Powered Suction Pump

S1001-3 S1001-3 Series

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

VOLTERA Powered Suction Pump

S1001-3 Series S1001-3 Series

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

VOLTERA Powered Suction Pump S1001-3 Series

રું. કે તે જે Conclusion

After analyzing bench tests, electrical safety testing data, it can be concluded that VOLTERA Powered Suction Pump, S1001-3 Series is substantially equivalent to the predicate device.

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

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 9, 2012

Suzric Enterprise Co., Ltd. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 77, Keji 1st Road Guishan Township Taoyuan County, 333 Taiwan

Re: K112853

Trade/Device Name: Voltera Powered Suction Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: October 02, 2012 Received: October 04, 2012

Dear Mr. Lee:

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 for assessed in the encreations of 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21

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

Page 2 – Mr. Michael Lee

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 de rice related adverse overse) (2) egulation (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indication for Use Statement

510(k) Number (if known): K112853

Device Name: VOLTERA Powered Suction Pump, S1001-3 Series

Indications for Use:

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 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. Ogden for mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112853

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.