(15 days)
No
The summary does not mention AI, ML, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (like automated analysis, segmentation, or diagnosis).
No
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic general ultrasound studies" and "provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures," which are diagnostic rather than therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states that the system is "intended to used to perform diagnostic general ultrasound studies," directly indicating its diagnostic purpose.
No
The intended use explicitly describes an "Ultrasound Probe System," which inherently involves hardware (the probe) to generate and receive ultrasound waves. The lack of a device description doesn't negate the hardware component implied by the system's function.
Based on the provided information, the NuWav Ultrasound Probe System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NuWav Ultrasound Probe System's intended use: The intended use clearly states that the system is used to perform diagnostic general ultrasound studies. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Therefore, the NuWav Ultrasound Probe System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
OYN, IYO, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging or fluid flow analysis
Anatomical Site
Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
0
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 |
1
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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
2
1999 - 1999 - 1999
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If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
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)
3
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
4
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | N | | | | | | | | Note 3 |
| Abdominal | | N | | | | | | | | Note 1
Note 3 |
| Intra-Operative (Specify)
(See note 4) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | Note 3 |
| Small Organ | | N | | | | | | | | Note 3
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
Conventional | | N | | | | | | | | |
| Muscular-Skeletal
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
5
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 1
Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
6
| 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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | P | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 1
Note 3 |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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 __
7
| 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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | P | | | | | | | | Note 3 |
| Intra-Operative | | | | | | | | | | |
| Intra-Operative
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | Note 2
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
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) |
|-----------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|---------------------|--------------------|
| Opthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-Operative (Specify) | | | | | | | | | | |
| Intra-Operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | P | | | | | | | | Note 2
Note 3 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Vascular | | | | | | | | | | |
| Peripheral -Vascular | | P | | | | | | | | Note 3 |
| Laparascopic | | | | | | | | | | |
| Muscular-Skeletal
Conventional | | | | | | | | | | |
| Muscular-Skeletal
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
10
| 510(k) Number:
Device Name:
Transducer: | NuWav Ultrasound Probe System
EC 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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(B - M) | Other
(Specify) | | | | | |
| Opthalmic | | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | | |
| Intra-Operative | | | | | | | | | | | | | | | |
| Intra-Operative
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
Conventional | | | | | | | | | | | | | | | |
| Muscular-Skeletal
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