TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS

K013849 · Tetrad Corp. · ITX · Dec 3, 2001 · Radiology

Device Facts

• Record ID: K013849
• Device Name: TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
• Applicant: Tetrad Corp.
• Product Code: ITX · Radiology
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Device Story

TETRAD ultrasound transducers (TC-EC7-ACP, -L5-ACP, -L7-ACP, -V4-ACP) function as peripheral components for Acuson Aspen and 128XP diagnostic ultrasound systems. Transducers convert electrical signals into acoustic energy for tissue imaging and fluid flow analysis, then receive reflected echoes to reconstruct images. Operated by clinicians in clinical settings, these devices provide real-time visual output on the host ultrasound system, aiding in diagnostic decision-making. Benefits include non-invasive visualization of internal structures and blood flow. The devices are functionally similar to predicate Acuson transducers, with acoustic output levels equal to or lower than the predicates.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on functional similarity and acoustic output measurements compared to predicate devices.

Technological Characteristics

Transducers feature 128-element arrays with silicone lenses. Center frequencies range from 4.0 MHz to 8.0 MHz. Bandwidth is 58-60% nominal. Elevation focus ranges from 20 mm to 90 mm. Pitch varies from 0.2 mm to 0.5 mm. Devices are designed for use with Acuson Aspen and 128XP systems.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, trans-rectal, trans-vaginal, small organ, neonatal cephalic, musculoskeletal, cardiac, and peripheral vessel applications, depending on the specific transducer model. Contraindicated for fetal Doppler applications on the Acuson 128XP system.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Acuson Aspen™ Ultrasound System (including Transducers EC7, L5, L7, V4) (K991805)

Reference Devices

• TETRAD TC-C3-ACP (K002193)

Submission Summary (Full Text)

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K013849
Page 1 of 2

# DEC 0 3 2001

## 510(k) Summary for TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers

- SPONSOR 1.
TETRAD Corporation 357 Inverness Drive, Suite A. Englewood, CO 80112-5866

Charles F. Hottinger, Ph.D., RAC, Contact Person: Regulatory Affairs Consultant

408-741-1006 Telephone:

Date Prepared: October 29, 2001

#### DEVICE NAME 2.

| Proprietary Name: | TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-<br>ACP Transducers |
|----------------------|---------------------------------------------------------------|
| Common/Usual Name: | Ultrasound Transducers |
| Classification Name: | Diagnostic Ultrasound Transducer<br>(21 CFR 892.1570, 90-ITX) |

#### PREDICATE DEVICES 3.

Acuson Aspen™ Ultrasound System, (including Transducers EC7, L5, L7, V4): K991805

#### INTENDED USE 4.

The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

#### DEVICE DESCRIPTION 5.

Technical specifications for the Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are as follows:

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K013849
Page 2 of 2

| Specifications | Tetrad TC-<br>EC7-ACP | Tetrad TC-<br>L5-ACP | Tetrad TC-<br>L7-ACP | Tetrad TC-V4-<br>ACP |
|---------------------|-----------------------|----------------------|----------------------|----------------------|
| Center Frequency | 7.0 MHz nominal | 6.0 MHz nominal | 8.0 MHz nominal | 4.0 MHz nominal |
| Number of Elements | 128 | 128 | 128 | 128 |
| Radius of Curvature | 12.5 | NA | NA | NA |
| Bandwidth -6dB | 60% nominal | 60% nominal | 60% nominal | 58% nominal |
| Elevation width | 6 mm | 4.1 mm | 4.1 mm | 15 mm |
| Elevation Focus | 22 mm | 20 mm | 20 mm | 90 mm |
| Lens material | Silicone | Silicone | Silicone | Silicone |
| Pitch | 0.2 mm | 0.3 mm | 0.3 mm | 0.5 mm |

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The TETRAD Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP Transducers are substantially equivalent to the corresponding Acuson products which are currently in commercial distribution in the United States, since the subject devices are functionally similar and have the same intended uses as the corresponding predicate transducers. The only substantive differences being the following points that were determined during the clearance of the TC-C3-ACP (an equivalent to the Acuson C3 Transducer) under K002193.

- . The TETRAD Transducers are not intended for Fetal Doppler applications on the Acuson 128XP (a Track 1 device).
- The acoustic output levels of the TETRAD Transducers are equal . to or slightly lower than those of their respective corresponding Acuson Transducers.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

TETRAD Corporation % Mr. Mark Job Program Manager TUV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K013849

R015647
Trade Name: TETRAD Model TC-EC7-ACP, TC-L5-ACP, TC-L7-ACP,TC-V4 ACP Transducers Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasound Transducer Regulatory Class: II Product Code: 90 ITX Dated: November 19, 2001 Received: November 20, 2001

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have to rearly we 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 mendments, 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 device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general vontrols pro risens or on, 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 rins decemination of backland 24XP Diagnostic Ultrasound Systems as described in your premarket notification:

### Transducer Model Number

| TC-L7-ACP |
|------------|
| TC-L5-ACP |
| TC-EC7-ACP |
| TC-V4-ACP |

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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. may pacined 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 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, you 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 – Mr. Job

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

7 Присутсвовал

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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KM
K013849

ACUSON Aspen and 128XP Systems________________________________________________________________________________________________________________________________________________ System: Transducer:TC-EC7-ACP

I ransucer. I C-ECT-AOI
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | Other |
|---------------------------|------------------------------------------------|-------------------|----|------|-----|-------------------|--------------------|-------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Dopplera | Combined<br>Modesb | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N1 | N1 | N1,c | | N1,c | N1,c | |
| | Abdominal | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | N1 | N1 | N1 | | N1 | N1 | |
| | Trans-vaginal | N1 | N1 | N1 | | N1 | N1 | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

ª Includes Color M, Power (Ampl.) Doppler.

6+M; B+PWD; B+Color Doppler, B+PWD+Color Doppler

Excludes Doppler or Doppler combination modes for Fetal application with 128XP

Additional Comments: N' : corresponding Acuson probe previously cleared under K991805.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Nancy Swazion

and Rad 510(k) Numb

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| Transducer: | TC-L5-ACP | | | | | | | | |
|---------------------------|------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------|------|-----|-------------------|--------------------|-------|--|
| | | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | | Mode of Operation | | | | | | |
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Dopplera | Combined<br>Modesb | Other | |
| Ophthalmic | Ophthalmic | | | | | N1,c | | | |
| Fetal Imaging<br>& Other | Fetal | N' | N' | N1,c | | N1,c | N' | | |
| | Abdominal | N' | N' | N' | | N' | N' | | |
| | Intra-operative (Specify) | | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | | |
| | Neonatal Cephalic | | | | | | | | |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | | |
| | Intra-luminal | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Other (Specify) | | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N' | N' | N' | | N' | N' | | |
| | Other (Specify) | | | | | | | | |

ACUSON Aspen and 128XP Systems_ Svstem:

N= new indication; P= previously cleared by FDA; E= added under Appendix E

ª Includes Color M, Power (Ampl.) Doppler

8+M; B+PWD; B+Color Doppler, B+PWD+Color Doppler.

Excludes Doppler or Doppler combination modes for Fetal application with 128XP

Additional Comments: N': corresponding Acuson probe previously cleared under K991805.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Nancy Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,

Radiological Devices
510(k) Number KC13849

{7}------------------------------------------------

ACUSON Aspen and 128XP Systems_ System: TC-L7-ACP Transducer: Transducer:

| Clinical Application | | Mode of Operation | | | | | Other | |
|---------------------------|------------------------------------------------|-------------------|----|------|-----|-------------------|-------|--------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Dopplera | | Combined<br>Modesb |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N1 | N1 | N1,c | | N1,c | N1,c | |
| | Abdominal | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-operative (Specify)d | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | N1 | N1 | N1 | | N1 | N1 | |
| | Neonatal Cephalic | N1 | N1 | N1 | | N1 | N1 | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | N1 | N1 | N1 | | N1 | N1 | |
| | Musculo-skel. (Superficial) | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N1 | N1 | N1 | | N1 | N1 | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N1 | N1 | N1 | | N1 | N1 | |
| | Other (Specify) | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

ª Includes Color M, Power (Ampl.) Doppler

6 +M; B+PWD; B+Color Doppler, B+PWD+Color Doppler.

Brill, BTF WD, DTOGIO, Doppler, Bir Fetal application with 128XP

9:Intra-operative: abdominal, cardiac.

.intra-operative: aboomillar, cardido:
Additional Comments: N': corresponding Acuson probe previously cleared under K91805. Additional Comments: N . Conresponding Addon problem. Controller on ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Janice C. Bragdon

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number _

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

ACUSON Aspen and 128XP Systems_ System: Transducer: TC-V4-ACP Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | Other |
|---------------------------|------------------------------------------------|-------------------|----|------|-----|-------------------|--------------------|-------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Dopplera | Combined<br>Modesb | |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N1 | N1 | N1,c | | N1,c | N1,c | |
| | Abdominal | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel.<br>(Conventional) | | | | | | | |
| | Musculo-skel. (Superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

ª Includes Color M, Power (Ampl.) Doppier

8+M; B+PWD; B+Color Doppler, B+PWD+Color Doppler.

Excludes Doppler or Doppler combination modes for Fetal application with 128XP

Additional Comments: N': corresponding Acuson probe previously cleared under K991805. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109)

Nancy Broadra

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number -