TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS

K014182 · Tetrad Corp. · ITX · Jan 3, 2002 · Radiology

Device Facts

• Record ID: K014182
• Device Name: TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
• Applicant: Tetrad Corp.
• Product Code: ITX · Radiology
• Decision Date: Jan 3, 2002
• 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-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

Device Story

TETRAD Model TC-ATP series are diagnostic ultrasound transducers designed for use with ATL HDI 3000 and HDI 5000 systems. Devices convert electrical signals to acoustic pulses and receive echoes to generate images or flow data. Operated by clinicians in clinical settings. Output displayed on host ultrasound system for diagnostic interpretation. Benefits include non-invasive visualization of internal structures and blood flow. Acoustic output levels are equal to or lower than predicate ATL transducers.

Clinical Evidence

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

Technological Characteristics

128-element ultrasound transducers; center frequencies 3.0-6.0 MHz; silicone lens material; various radii of curvature (8-76 mm). Connectivity via host ATL HDI 3000/5000 systems. Class II device.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis. Specific applications vary by transducer model: TC-C52-ATP (Fetal, Abdominal); TC-C84V-ATP (Fetal, Trans-vaginal); TC-C95-ATP (Fetal, Trans-rectal, Trans-vaginal); TC-CLA76-ATP (Fetal, Abdominal); TC-L74-ATP (Abdominal, Intra-operative, Small Organ, Neonatal Cephalic, Musculo-skeletal, Cardiac, Peripheral vessel). Prescription use only.

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

• ATL HDI 3000 and HDI 5000 Systems (including Transducers C5-2, C8-4V, C9-5, C3.5, R76, L7-4)

Reference Devices

• TC-C3-ATP (K002193)

Submission Summary (Full Text)

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K0191182

# JAN 0 3 2002

## 510(k) Summary for TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP 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

Telephone: [phone]

November 27, 2001 Date Prepared:

#### 2. DEVICE NAME

Proprietary Name:

Common/ Usual Name:

TETRAD Model TC-C52-, -C84V--L74-ATP Transducers Ultrasound Transducers

Diagnostic Ultrasound Transducer Classification Name: (21 CFR 892.1570, 90-ITX)

#### 3. PREDICATE DEVICES

ATL HDI 3000 and HDI 5000 Systems (including Transducers C5-2, C8-4V, C9-5, C3.5, R76, L7-4. The C5-2 and L7-4 were most recently cleared for use with the HDI 5000 under K002003.

#### INTENDED USE 4.

The TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

RA
#

#### 5. DEVICE DESCRIPTION

Technical specifications for the Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are as follows:

SK50

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| Specifications | Tetrad TC-<br>C52-ATP | Tetrad TC-<br>C84V-ATP | Tetrad TC-<br>C95-ATP | Tetrad TC-<br>CLA76-ATP | Tetrad TC-<br>L74-ATP |
|---------------------|-----------------------|------------------------|-----------------------|-------------------------|-----------------------|
| Center Frequency | 3.0 MHz<br>nominal | 6.0 MHz<br>nominal | 6.0 MHz<br>nominal | 4.0 MHz<br>nominal | 6.0 MHz<br>nominal |
| Number of Elements | 128 | 128 | 128 | 128 | 128 |
| Radius of Curvature | 40 mm | 12 mm | 8 mm | 76 mm | NA |
| Bandwidth -6dB | 70% nominal | 60% nominal | 60% nominal | 50% nominal | >50% |
| Elevation width | 15 mm | 5.5 mm | 4 mm | 15 mm | 5.5 mm |
| Elevation Focus | 80 mm | 25 mm | 25 mm | 75 mm | 25 mm |
| Lens material | silicone | Silicone | silicone | silicone | silicone |
| Pitch | 0.3 mm | 0.2 mm | 0.15 mm | 0.6 mm | 0.2 mm |

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The TETRAD Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP Transducers are substantially equivalent to the corresponding ATL 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-ATP (an equivalent to the Acuson C3 Transducer) under K002193.

The acoustic output levels of the TETRAD Transducers are equal to or slightly lower than those of their respective corresponding ATL Transducers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 3 2002

TETRAD Corporation % Mr. Mark Job TÜV Product Services, Inc. 1775 Old Highway 8 NW Suite 104 NEW BRIGHTON MN 55112-1891 '

Re: K014182

Trade Name: TETRAD Transducer Models: TC-C52-ATP, TC-C84V-ATP, TC-C95-ATP,

TC-CLA76-ATP, TC-L74-ATP

Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: December 19, 2001 Received: December 20, 2001

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 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the ATL HDI 3000 and HDI 5000 Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

TC-C52-ATP TC-C84V-ATP TC-C95-ATP TC-CLA76-ATP TC-L74-ATP

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

Sincerely yours,

Nancyc brogdon

**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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ATL HDI 3000 and HDI 5000 Systems_____________________________________________________________________________________________________________________________________________ System: Transducer: TC-C52-ATP

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 | | | | | | | |
| | Fetal | N1 | N1 | N1 | | N1 | N1 | |
| | 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 | | | | | | | |
| | 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) | | | | | | | |

N = new indication: predicate (ATL C5-2) cleared for this use with ATL HDI 3000 and ATL HDI 5000; a Includes Color M, Power (Ampl.) Doppler.

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

(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 C. Brogdon |
|---------------------------------------------------------------|------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K014182 |

公

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| System: | ATL HDI 3000 and HDI 5000 Systems |
|-------------|-----------------------------------|
| Transducer: | TC-C84V-ATP |

I ransuccr. I O Go v 7 N
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|--------------------------|------------------------------------------------|-------------------|----|-----|-----|-------------------|--------------------|-------|
| General | Specific | B | M | PWD | CWD | Color<br>Dopplera | Combined<br>Modesb | Other |
| (Track I Only) | (Tracks I & III) | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | N1 | N1 | N1 | | N1 | N1 | |
| | Abdominal | | | | | | | |
| | 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 | | | | | | | |
| | 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: predicate (ATL C8-4V) cleared for this use with ATL HDI 3000 and ATL HDI 5000; a Includes Color M, Power (Ampl.) Doppler

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

(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)

Dancie brogdon

(Division Sign Division of Reproduct and Radiological Devic 510(k) Number

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ATL HDI 3000 and HDI 5000 Systems_ System: Transducer:TC-C95-ATP 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 | | | | | | | |
| | Fetal | N1 | N1 | N1 | | N1 | N1 | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify)d | | | | | | | |
| | 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 | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N'= new indication: predicate (ATL C9-5) cleared for this use with ATL HDI 3000 and ATL HDI 5000; a Includes Color M, Power (Ampl.) Doppler

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

(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 C. Brogdon

(Division Sigt Division of Reproduc and Radiological Devi 510(k) Numbe

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| System: | ATL HDI 3000 | | | | | | | |
|--------------------------------------------------------------------------------------------------|------------------------------------------------|-------------------|----|-----|-----|-------------------|--------------------|-------|
| Transducer: | TC-CLA76-ATP | | | | | | | |
| 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 | | | | | | | |
| Fetal Imaging<br>& Other | Fetal | N1 | N1 | N1 | | N1 | N1 | |
| | 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) | | | | | | | |

N'= new indication: predicate (ATL C3.5R76) cleared for this use with ATL HDI 3000;

a Includes Color M, Power (Ampl.) Doppler

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

(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 Reproduct ve. Abdon and Radiological Device 510(k) Number

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ATL HDI 3000 and HDI 5000 Systems____ System:

Transducer:TC-L74-ATP Transucer. TO-L7+ATT
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 | | | | | | | |
| | Abdominal | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-operativec (Specify) | N1 | N1 | N1 | | N1 | N1 | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | 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 Adultd | N1 | N1 | N1 | | N1 | N1 | |
| | Cardiac Pediatricd | N1 | N1 | N1 | | N1 | N1 | |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | N1 | N1 | N1 | | N1 | N1 | |
| | Other (Specify) | | | | | | | |

N = new indication: predicate (ATL L.7-4) cleared for this use with ATL HDI 3000 and ATL HDI 5000; a Includes Color M, Power (Ampl.) Doppler

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

°Intra-operative: abdominal, thoracic and PV.

Uncludes cardiac analysis

(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 C. Brogdon

(Division Sig Division of Reproductive, Abdon and Radiological Devic 510(k) Number