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.

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:
a. Collection canister (secretion container),
b. Related hoses (tubing)
c. Hose connectors
d. Filters
e. Other accessories as detailed in the operating manual

AI/ML Overview

The NovaSpine Powered Suction Pump PRO-I is a medical device. The provided text, a 510(k) summary, describes its characteristics and regulatory clearance, but does not contain information about a study that proves the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to other legally marketed devices, rather than presenting a performance study with detailed acceptance criteria and results. The "Device Description" section lists several specifications, which likely serve as the device's inherent design and performance characteristics, but these are not presented as "acceptance criteria" against which a study was performed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study as requested, because the provided text does not describe such a study or associated acceptance criteria.

Here's what can be extracted from the text regarding the device specifications:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present explicit "acceptance criteria" tested in a study. Instead, it provides the device's technical specifications. If we interpret these specifications as the intended performance characteristics, the table would look like this:

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Suction	(Not explicitly stated as criteria, but expected performance)	9 liters/min
Maximum Vacuum	(Not explicitly stated as criteria, but expected performance)	200 mmHg
Noise	(Not explicitly stated as criteria, but expected performance)	35 dba
Weight	(Not explicitly stated as criteria, but expected performance)	2.8 kg
Operation	(Not explicitly stated as criteria, but expected performance)	Continuous and Intermittent
Dimensions	(Not explicitly stated as criteria, but expected performance)	290mmX359mmX130mm

The following information cannot be provided as it is not present in the given text:

Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used.
The sample size for the training set.
How the ground truth for the training set was established.

This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices, which typically involves comparing technical specifications, intended use, and safety/effectiveness profiles without necessarily requiring new clinical performance studies against formal acceptance criteria for every new device. It's a common pathway for Class I and II medical devices.

Summary

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Nova®Spine LLC

062456

page

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 LLC15 Heritage CourtTarrytown, NY 10591Telephone: 914-909-6577Fax: 914-909-6577E-mail : hkhosrow@optonline.net
510(k) Contact:	Dina L. Weissman, J.D.P.O. Box 205Derby CT 06418Telephone: (203) 736-8631Email: dina.weissman@sbcglobal.net
Manufacturer:	Asskea (Simex) Medizintechnik, GmbHSchlefweg 25, D-99718, Greussen, Germany
Trade Name:	NovaSpine Powered Suction Pump PRO-I
Common Name:	Powered Suction Pump
Classification:	FDA 21 CFR 878.4780Powered Suction PumpClass II, Code: BTA
Device Product Code	BTA - Pump, Portable, Aspiration, (Manual orPowered)
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 isindicated for patients who would benefit from a suctiondevice particularly as the device may promote woundhealing or for the aspiration and removal of surgicalfluids, tissue (including bone), gases, bodily fluids orinfectious materials from a patient's airway orrespiratory support system either during surgery or at thepatient's bedside.
Page 1 of 2

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Nova Spine LLC

Kc62456 xaye

PO Bax 969 Elmsford, NY 10523

Device Description:

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:

1. The pump and battery pack are all housed in a single unit. The charging unit is a separate stand alone device.
1. 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

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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

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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

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Indications for Use Statement

510(k) Number:

Device Name:

NovaSpine Powered Suction Pump PRO-I

Indication for Use:

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

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.