(407 days)
Not Found
No
The summary describes a standard negative pressure wound therapy pump with no mention of AI or ML capabilities. The performance studies focus on physical and mechanical testing, not algorithmic performance.
Yes
The device is indicated for wound management via the application of negative pressure for the removal of fluids and excess exudate, infectious material, and tissue debris, which may promote wound healing for various types of wounds, directly contributing to patient therapy.
No
The device is described as a "Powered Suction Pump" intended for "wound management via the application of negative pressure for removal of fluids and excess exudate, infectious material, and tissue debris." Its function is to remove materials from wounds to promote healing, which is a therapeutic function, not a diagnostic one. It does not identify conditions, diseases, or provide any diagnostic information.
No
The device description clearly states it is a "lightweight, suction device" and a "pump," which are physical hardware components. It also mentions being connected to a "disposable canister" and operating via "mains power supply or internal battery," further indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The VOLTERA Powered Suction Pump is a device that applies negative pressure directly to a wound on the patient's body to remove fluids and debris. This is a therapeutic treatment applied in vivo (within the body), not a diagnostic test performed on a sample in vitro.
- Intended Use: The intended use clearly describes wound management and removal of exudate from various types of wounds. This is a treatment, not a diagnostic process.
The device description and intended use clearly indicate a therapeutic device used for wound care, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
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.
Product codes
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 County |
| 333, 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
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.
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 Powered
Suction Pump,
S1001-3 Series) | Predicate Device
(NovaSpine Powered
Suction Pump PRO-I,
K062456) | Predicate Device
(Prospera PRO-I,
PRO-II and PRO-III
Negative Pressure
Wound Therapy
System, K112458) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Code or Federal
Regulations | 878.4780 | 878.4780 | 878.4780 |
| Prescription
Medical Devices | YES | YES | YES |
| Intended Use | 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 | The NovaSpine
Powered Suction Pump
PROMI is indicated
for patients who would
benefit from a suction
device particularly as
the device may
promote wound
healing or for the
aspiration and removal | The Prospera Negative
Pressure Wound
Therapy System is
indicated for patients
that would benefit
from a suction device
particularly as the
device may promote
wound healing by
removal of wound |
| | 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. | of surgical fluids,
tissue (including
bone), gases, bodily
fluids or infectious
materials from a
patient's airway or
respiratory support
system either during
surgery or at the
patient's bedside. | exudate, debris, and
infectious material or
for the aspiration and
removal of surgical
fluids, tissue
(including bone),
gases, bodily fluids or
infectious material
from the patient's
airway or respiratory
support system. The
Prospera Negative
Pressure Wound
Therapy may be used
during surgery or at the
patient's bedside and is
indicated for home use. |
| Model | S1001-3 Series | PRO-I | PRO-I, PRO-II,
PRO-III |
| Indications
for
Use | The Voltera suction
pump is indicated on
use with patients with
the following wounds:
Traumatic
Dehisced wounds
Partial thickness
burns (the
epidermis and
some portion of
the dermis have
been burned or | For management of
chronic, acute,
traumatic, sub acute
and dehisced wounds,
partial thickness burns,
ulcers (such as diabetic
or pressure), flaps and
grafts. | For management of
chronic, acute,
traumatic, sub acute
and dehisced wounds,
partial thickness burns,
ulcers (such as diabetic
or pressure), flaps and
grafts. |
| | injured) | | |
| | Chronic wounds | | |
| | (pressure | | |
| | ulcers,diabetic | | |
| | foot ulcers, venous | | |
| | leg ulcers) | | |
| | Acute wounds | | |
| | Traumatic | | |
| | Flaps and grafts | | |
| Contraindications | Contraindicated for
patients with the
following conditions:
- Presence of
necrotic tissue - Malignancy
- Untreated
Osteomyelitis - Untreated
malnutrition - Exposed arteries,
veins, nerves, or
organs - Use over
anastomotic sites | The PRO-I is
contraindicated in the
presence of: - Necrotic tissue
- Unexplored or
non-enteric
fistulas - Untreated
osteomyelitis - Malignancy in the
wound - Exposed arteries,
veins, or organs | The PRO-I, PRO-II,
PRO-III is
contraindicated in the
presence of: - Necrotic tissue
- Unexplored or
non-enteric
fistulas - Untreated
osteomyelitis - Malignancy in the
wound - 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 190
cm | Noise: 35 dba | Noise: 35 dba |
| | Weight: 1.35 kg | Weight: 2.8 kg | Weight: 1.82.8 kg |48hrs depending | 24
| | 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: |
| | 2448hrs depending | 2448hrs depending |
| | on use | on use | on use |
| | Dimensions: | Dimensions: | Dimensions: |
| | 17016090 mm | 290359130 mm | 290359130 mm |
| Consumable/
Disposable
components | 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:
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.
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