NUWAV

K081781 · Laborie Medical Technologies, Corp. · IYO · Jul 9, 2008 · Radiology

Device Facts

• Record ID: K081781
• Device Name: NUWAV
• Applicant: Laborie Medical Technologies, Corp.
• Product Code: IYO · Radiology
• Decision Date: Jul 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

Device Story

NuWav Ultrasound Probe System utilizes mechanical sector transducers to acquire diagnostic ultrasound images; system processes acoustic signals to generate B-mode images for clinical visualization. Used in clinical settings by healthcare professionals for diagnostic studies including fetal, abdominal, cardiac, and musculoskeletal imaging; also supports biopsy guidance and needle placement. Output displayed on system monitor for real-time clinical assessment; assists clinicians in anatomical evaluation and procedural guidance. Benefits include non-invasive diagnostic imaging and improved accuracy for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with acoustic output requirements per FDA guidance (September 30, 1997) is required.

Technological Characteristics

Mechanical sector ultrasound transducers; operating frequencies ranging from 3.5 MHz to 12 MHz. System supports B-mode imaging. Connectivity via USB interface. Sterilization/disinfection per manufacturer instructions for clinical use.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac, trans-vaginal, trans-rectal, peripheral vascular, and musculoskeletal applications. Includes imaging for biopsy guidance and needle placement. No specific age or gender contraindications listed.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• K951976
• K070907

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, with three lines representing the snakes and a base representing the staff. The overall design is simple and recognizable, representing the department's focus on health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2008

Laborie Medical Technologies, Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K081781

Trade/Device Name: NuWay Ultrasound Probe System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: OYN, IYO, and ITX Dated: June 23, 2008 Received: June 24, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalente(for the indications for use stated in the enclosure) to legally marketed predicate devices marked 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). You may, therefore, market the drevise, or ute 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.

This determination of substantial equivalence applies to the following transducers intended for use with the NuWay Ultrasound Probe System, as described in your premarket notification:

Transducer Model Number

| GP 3.5 MHz |
|------------|
| GP 5.0 MHz |
| SP 7.5 MHz |
| SF 7.5 MHz |
| MV 12 MHz |
| EC 7.5 MHz |

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, vou submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

Voruit Mr Whay

Grogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure(s)

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# Indications for Use

510(k) Number (if known):

Device Name: NuWav Ultrasound Probe System

The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

For Prescription Use X Over-the -Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Amal Nitz

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices K 081781 510(k) Number __

Page 1 of 1

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### SECTION 4.3

### INDICATIONS FOR USE

# Ultrasound Device Indications For Use

510(k) Number: Device Name:

#### NuWav Ultrasound Probe System

Indications for Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | | | | | | | | Note 3 |
| Abdominal | | N | | | | | | | | Note 1<br>Note 3 |
| Intra-Operative (Specify)<br>(See note 4) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 3 |
| Small Organ | | N | | | | | | | | Note 3<br>Note 2 |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | N | | | | | | | | Note 3 |
| Trans-Vaginal | | N | | | | | | | | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | N | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | N | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | N | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

N=1 New Indication

Note 1: Abdominal, Solid organs, Aneurysms, Bladder. Note 2: Small Organ: breast, thyroid, testes, prostate.

Note 3: includes imaging for guidance of blopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Indications for Use

(Division Sign-Off) Section 4.3, Page 1 of 7 Division of Reproductive, Abdominal and Radiological Devices V 08 1 78 510(k) Number

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510(k) Number: Device Name: Transducer:

NuWav Ultrasound Probe System GP 3.5 MHz Mechanical Sector Probe

Indications for Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | Mode of Operation | |
|--|-------------------|--|
| | | |

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 1<br>Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P=Previously Cleared, in K951976 and referenced K070907

Note 1: Abdominal, Solid organs, Aneurysms, Bladder.

Note 2: Small Organ: breast, thyroid, testes, prostate.

Note 3: Includes Imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

(Division Sign-Off)

Indications for Use

Division of Reproductive, Abdominal and Section 4.3. Page 2 of 7 Radiological Devices 510(k) Number K081781

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| 510(k) Number: | |
|----------------------|------------------------------------------------------|
| Device Name: | NuWav Ultrasound Probe System |
| Transducer: | GP 5.0 MHz Mechanical Sector Probe |
| Indications for Use: | Diagnostic ultrasound Imaging or fluid flow analysis |

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

#### Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 1<br>Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2 |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P=Previously Cleared in K951976 and referenced K070907 Note 1: Abdominal, Solid organs, Aneurysms, Bladder. Note 2: Small Organ: breast, thyroid, testes, prostate. Note 3: Includes Imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Arput Mr. Whg

Indications for Use

Division of Reproductive, Abdominal and Section 4.3, Page 3 of 7 Radiological Devices 510(k) Number __

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| 510(k) Number: | NuWav USB Ultrasound Probe System |
|----------------------|-------------------------------------------------------------|
| Device Name: | |
| Transducer: | SP 7.5 MHz Mechanical Sector Probe |
| Indications for Use: | Diagnostic ultrasound imaging or fluid flow analysis of the |

human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 3 |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2 |
| Neonatal Cephalic | | P | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P=Previously Cleared in K951976 and referenced K070907 Note 2: Small Organ: breast, thyroid, testes, prostate. Note 3: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jomi M. Whz

Section 4.3, Page 4 of 7

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Indications for Use

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

510(k) Premarket Notification

NuWav Ultrasound Probe System

# Ultrasound Device Indications For Use

510(k) Number: Device Name: Transducer:

#### NuWav USB Ultrasound Probe System SF 7.5 MHz Mechanical Sector Probe

Indications for Use:

#### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | Note 2<br>Note 3 | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | P | | | | | | | | Note 3 |
| Trans-Vaginal | | P | | | | | | | | Note 3 |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

P=Previously Cleared K951976 and referenced K070907 Note 2: Small Organ: breast, thyroid, testes, prostate. Note 3: Includes imaging for guidance of blopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

forgath wh

Indications for Use

(Division Sign-Off) Section 4.3, Page 5 of 7 Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

{9}------------------------------------------------

| 510(k) Number: | |
|----------------|-----------------------------------|
| Device Name: | NuWav Ultrasound Probe System |
| Transducer: | MV 12 MHz Mechanical Sector Probe |

Indications for Use:

#### Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2<br>Note 3 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | Note 3 |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | |

Previously Cleared; K070907

Note 2: Small Organ: breast, thyroid, testes, prostate. Note 3: Includes imaging for guidance of biopsy

Concurrence of CDRH, Offica of Device Evaluation (ODE)

Aogul Mothy

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices

Indications for Use

Section 4.3, Page 6 of 7

510(k) Number ________________________________________________________________________________________________________________________________________________________________

K0817-81

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| 510(k) Number:<br>Device Name:<br>Transducer: | NuWav Ultrasound Probe System<br>EC 7.5 MHz Mechanical Sector Probe | | | | | | | | | | | | | | |
|-----------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|--|--|--|--|--|
| Indications for Use: | | Diagnostic ultrasound Imaging or fluid flow analysis of the<br>human body as follows:<br>Mode of Operation | | | | | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(B - M) | Other<br>(Specify) | | | | | |
| Opthalmic | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | | | | | |
| Intra-Operative<br>Neurological | | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | | | |
| Trans-Rectal | | P | | | | | | | | Note 3 | | | | | |
| Trans-Vaginal | | P | | | | | | | | Note 3 | | | | | |
| Trans-Urethral | | | | | | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | | | | | | |
| Peripheral -Vascular | | | | | | | | | | | | | | | |
| Laparascopic | | | | | | | | | | | | | | | |
| Muscular-Skeletal<br>Conventional | | | | | | | | | | | | | | | |
| Muscular-Skeletal<br>Superficial | | | | | | | | | | | | | | | |
| Others (Specify) | | | | | | | | | | | | | | | |

P=Previously Cleared, K951976 and referenced K070907
Note 3: Includes imaging for guidance of blopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Indications for Use

I tersion of Reproductive, Abdominal and Sadiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Section 4.3, Page 7 of 7