(54 days)
Not Found
No
The description focuses on the mechanical and electrical components of a standard suction pump and does not mention any AI or ML capabilities.
No.
The device is a suction pump designed to remove fluids, tissue, and other materials from a patient's body, which is a supportive rather than a therapeutic function. While it mentions promoting wound healing, its primary mechanism of action is mechanical removal, not direct therapy.
No
Explanation: The device is described as a suction pump used for the aspiration and removal of fluids, tissue, and other materials. Its function is to remove substances, not to identify or analyze a condition, which is characteristic of a diagnostic device.
No
The device description clearly outlines a physical, battery-powered pump with specific hardware components (pump, battery pack, charging unit, collection canister, hoses, etc.) and physical specifications (weight, dimensions, noise level, suction rate, maximum vacuum). This is not a software-only device.
Based on the provided information, the NovaSpine Powered Suction Pump PRO-I is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the aspiration and removal of fluids, tissue, gases, and infectious materials from a patient's airway or respiratory support system. This is a direct medical intervention on the patient's body.
- Device Description: The description details a pump that creates negative pressure to physically remove substances from the patient. This is a mechanical function, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the living body) to provide diagnostic information about a patient's health status. IVD devices are typically used for tests like blood glucose monitoring, pregnancy tests, or tests for infectious diseases.
The NovaSpine Powered Suction Pump PRO-I is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NovaSpine Powered Suction Pump PRO-I 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 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.
Product codes
BTA, OMP
Device Description
The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:
- Suction: 9 liters/min,
- Maximum Vacuum: 200 mmHg
- Noise: 35 dba,
- Weight: 2.8 kg
- Operation: Continuous and Intermittent
- Dimensions: 290mmX359mmX130mm
The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.
The NovaSpine Powered Suction Pump PRO-I is composed of two parts:
-
- The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
-
- The consumable/disposable components such as:
- Collection canister (secretion container), a.
- Related hoses (tubing) b.
- Hose connectors c.
- d. Filters
- Other accessories as detailed in the operating manual e.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
During surgery or at the patient's bedside.
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
Not Found
Key Metrics
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
Nova®Spine LLC
062456
page
Z
:
| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Safe Medical Devices Act of 1990 (SMDA) | |
| 510(k) Summary OCT 16 20 | |
| Date prepared: | September 27, 2006 |
| Name of Firm: | NovaSpine LLC |
| 15 Heritage Court | |
| Tarrytown, NY 10591 | |
| Telephone: 914-909-6577 | |
| Fax: 914-909-6577 | |
| E-mail : hkhosrow@optonline.net | |
| 510(k) Contact: | Dina L. Weissman, J.D. |
| P.O. Box 205 | |
| Derby CT 06418 | |
| Telephone: (203) 736-8631 | |
| Email: dina.weissman@sbcglobal.net | |
| Manufacturer: | Asskea (Simex) Medizintechnik, GmbH |
| Schlefweg 25, D-99718, Greussen, Germany | |
| Trade Name: | NovaSpine Powered Suction Pump PRO-I |
| Common Name: | Powered Suction Pump |
| Classification: | FDA 21 CFR 878.4780 |
| Powered Suction Pump | |
| Class II, Code: BTA | |
| Device Product Code | BTA - Pump, Portable, Aspiration, (Manual or |
| Powered) | |
| Substantial Equivalency | Kinetic Concepts K971548 |
| "AmbuVAC" | |
| Blue Sky Medical Group, Inc. K042134 | |
| "Versatile 1 Wound Vacuum System" | |
| NovaSpine LLC K061133 | |
| "SIMEX Suction Pump" | |
| Indications for Use | The NovaSpine Powered Suction Pump PRO-I 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 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. | |
| Page 1 of 2 |
1
Nova Spine LLC
Kc62456 xaye
PO Bax 969 Elmsford, NY 10523
Device Description:
The NovaSpine Powered Suction Pump PRO-I is a lightweight, self contained, portable battery powered, aspiration pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous or intermittent negative pressure. The NovaSpine Powered Suction Pump PRO-I is available in only one model:
| Table 1 | |
|---|---|
| 1. | Suction: 9 liters/min, |
| 2. | Maximum Vacuum: 200 mmHg |
| 3. | Noise: 35 dba, |
| 4. | Weight: 2.8 kg |
| 5. | Operation: Continuous and Intermittent |
| 6. | Dimensions: 290mmX359mmX130mm |
The pump is powered with a rechargeable Nickel-metal Hydride (NiMh) battery. The unit includes a port for an external power supply and/or a battery charger.
The NovaSpine Powered Suction Pump PRO-I is composed of two parts:
-
- The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
-
- The consumable/disposable components such as:
- Collection canister (secretion container), a.
- Related hoses (tubing) b.
- Hose connectors c.
- d. Filters
- Other accessories as detailed in the operating manual e.
Basis For Substantial Equivalence:
This product is substantially equivalent to similar technical specifical specifications currently on the market such as:
Kinetic Concepts K 971548 Ambu VAC Blue Sky Medical Group, Inc. K042134 Versatile 1 Wound Vacuum System NovaSpine, LLC K061133 SIMEX Suction Pump
Page 2 of 2
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling an eagle or a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
APR -7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NovaSpine, LLC % Weissman Law Firm Ms. Dina L. Weissman. J.D. P.O. Box 205 Derby, Connecticut 06418
Re: K062456
Trade/Device Name: NovaSpine Powered Suction Pump PRO-1 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: August 18, 2006 Received: August 23, 2006
Dear Ms. Weissman:
This letter corrects our substantially equivalent letter of December 16, 2006.
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 (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.
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
3
Page 2 - Ms. Dina L. Weissman
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
R.C. Hatto
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number:
Device Name:
NovaSpine Powered Suction Pump PRO-I
Indication for Use:
The NovaSpine Powered Suction Pump PRO-I 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 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.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
Division of General, Restorative, and Neurological Devices
510(k) Number_K062456