ULTRASOUND SCANNER, TYPE 1101

K023457 · B-K Medical A/S · IYO · Nov 1, 2002 · Radiology

Device Facts

• Record ID: K023457
• Device Name: ULTRASOUND SCANNER, TYPE 1101
• Applicant: B-K Medical A/S
• Product Code: IYO · Radiology
• Decision Date: Nov 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Ultrasound Scanner Type 1101 is a diagnostic ultrasound system utilizing linear, convex, and mechanical sector transducers. Device captures acoustic signals to generate B-mode and M-mode images; supports geometric measurements and calculations for urology, cardiology, and OB/GYN applications. System provides needle guidance for biopsy and puncture procedures. Operated by clinicians in clinical settings. Acoustic output is monitored via Track 3 index display (Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0). Output displayed to healthcare provider for diagnostic assessment and procedural guidance. Benefits include non-invasive visualization of internal structures and real-time guidance for interventional procedures.

Clinical Evidence

Bench testing only. System safety verified via IEC 60601-1, UL2601, CSA22.2 No 601-1, and EN60601. Acoustic output measured per AIUM 1998 standards. Patient contact materials comply with ISO 10993-1. No clinical trial data provided.

Technological Characteristics

Diagnostic ultrasound system using linear, convex, and mechanical sector arrays. Patient contact materials compliant with ISO 10993-1. Operates in B-mode and M-mode. Acoustic output: Ispta ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0. Safety standards: IEC 60601-1, UL2601, CSA22.2 No 601-1. Track 3 acoustic output reporting.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ (breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes), cardiac, transrectal, transvaginal, and musculoskeletal (conventional and superficial) applications.

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

• Sonoline Elegra Diagnostic Ultrasound System (K980557)

Submission Summary (Full Text)

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K0 23457P1

# Attachment 1: 510(k) Summary:

1 2002 NOV

This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: B-K Medical A/S Address: Mileparken 34, DK2820Gentofte, Denmark Phone: [phone] Fax: Contact person: Villy Braender, Quality Assurance Mnager Date prepared: 30.September, 2002

Trade name: Ultrasound Scanner Type 1101 Common name: Diagnostic Ultrasound System Classification names: Ultrasonic Pulsed Echo Imaging System (90 IYO, CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed device: Siemens Medical Systems: Sonoline Elegra Diagnostic Ultrasound System (K980557)

# Device description:

1101 supports the following scanning modes and combinations thereof: B-mode M-mode.

The system can perform simple geometric measurements, and perform calculations in the areas of Urology, Cardiology and OB/GYN applications.

The system can guide biopsy- and puncture needles.

### Transducers

Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 1101 are Track 3 transducers.

#### Acoustic output

The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and MI ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0. i.e. TI ≤ 6.0

### Clinical measurement accuracy.

Clinical measurements and calculations are described and accuracies are provided in the User Guide.

# Thermal, mechanical and electrical safety.

The scanner 1101 has been tested by a recognized, certified body according to IEC 60601-1 .

### Acoustic Output Reporting

The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH. September 30, 1997"

The acoustic output is measured and calculated according to: "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (AIUM 1998).

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Att. 1

Intended use.

See comparison below

# Technological characteristics compared to the predicate device.

The predicate device has the same major technological characteristics as the subject device, see comparison below.

Comparison with K980557, Sonoline Elegra (Siemens Medical Systems).

| | Type 1101 in this application | K980557, Sonoline Elegra |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended uses | Abdominal, Cardiac, Fetal,<br>Intraoperative, Neurosurgery,<br>Pediatrics, Transrectal, Small<br>organs, Transvaginal,<br><br>Musculoskeletal (superficial,<br>conventional) | General Radiology,<br>Abdominal,Intraoperative,Sma<br>ll parts, transcranial,OB/GYN,<br>Neonatal/Adult Cephalic,<br>Urology, Vascular,<br>Musculoskeletal, Superficial<br>Musculoskeletal, Peripheral<br>Vascular |
| General device description | B,M and combination modes,<br>Track 3 (Index display).<br>Measurements | B,M Color, PW, CW and<br>combination modes. Track 3<br>(Index display).<br>Measurements. |
| Acoustic output | Ispta ≤ 720 mW/cm² and MI ≤<br>1.9 (Track 3, non ophthalmic).<br>TI ≤ 6.0 | Not in 510(k)summary, except<br>that it has index display<br>according to Display standard. |
| General safety and<br>effectiveness | UL2601, CSA22.2 No 601-1,<br>EN60601, 93/42/EEC Medical<br>Devices Directive,<br>AIUM/NEMA Display<br>standard, EN/ISO 10993-1 | UL2601, CSA22.2 No 601-1,<br>EN60601,93/42/EEC Medical<br>Devices Directive,<br>AIUM/NEMA Display<br>standard |

Conclusion: The device 1101 in this application has similar intended uses, and in particular the subject for the application , musculo-skeletal, is the same.

B-K Medical A/S therefore believes, that 1101 is substantially equivalent to K980557.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure with three overlapping profiles, suggesting a sense of community and interconnectedness.

#### Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

Mr. Villy Brænder Official Correspondant B-K Medical A/S Mileparken 34 DK-2730 Herlev DENMARK

Re: K023457

Trade Name: Ultrasound Scanner Type 1101 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: October 7, 2002 Received: October 15, 2002

Dear Mr. Brænder:

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 Ultrasound Scanner Type 1101, as described in your premarket notification:

Transducer Model Number

8560 8570

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Page 2 - Mr. Brænder

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 (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 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".

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

Sincerely yours,

David A. Lignon

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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# Diagnostic Ultrasound Indications for Use Form

#### System: 1101

# Fill out one form for each ultrasound system and each transducer.

Intended 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>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | X | X | | | | | | X (B+M) | |
| Abdominal | | X | X | | | | | | X (B+M) | |
| Intraoperative (specify) | | X | X | | | | | | X (B+M) | |
| Intraoperative Neurological | | X | X | | | | | | X (B+M) | |
| Pediatric | | X | X | | | | | | X (B+M) | |
| Small Organ (specify) | | X | X | | | | | | X (B+M) | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | X | X | | | | | | X (B+M) | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | X | X | | | | | | X (B+M) | |
| Transvaginal | | X | X | | | | | | X (B+M) | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | X | X | | | | | | X (B+M) | |
| Musculo-skeletal Superficial | | X | X | | | | | | X (B+M) | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:_

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Erich G. Heymann

Division 5 : UK) Number

Prescription Use (Per 21 CFR 801.109)

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| System: | 1101 |
|-------------|------|
| Transducer: | 8560 |

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

| Clinical Application | | | Mode of Operation | | | | | Other*<br>(Specify) |
|---------------------------|------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | P | | | | P (B+M) | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | P | P | | | | P (B+M) | |
| | Small Organ (Specify) | P | P | | | | P (B+M) | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | N | N | | | | N (B+M) | |
| | Musculo-skel. (Superficial) | N | N | | | | N (B+M) | |
| | 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

* Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: Intraoperative: Breast, liver, pancreas, biliary system Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes

(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

Thmil A. Sayan

of Renroducti Radiological Devic : (k) Number

Prescription Use (Per 21 CFR 801.109)

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# DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| System: | 1101 |
|-------------|------|
| Transducer: | 8570 |

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>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging<br>& Other | Pediatric | E | E | | | | E (B+M) | |
| | Small Organ (Specify) | E | E | | | | E (B+M) | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Conventional) | N | N | | | | N (B+M) | |
| | Musculo-skel. (Superficial) | N | N | | | | N (B+M) | |
| | 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 (to K002085) under Appendix E * Examples may include: A-mode, Amplitude Doppler, 3-D Imaging, Tissue Motion Doppler, Color Velocity Imaging

Additional Comments: Intraoperative: Breast, liver, pancreas, biliary system Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes

(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

David A. Kyser

, i : Xk) Numb

Prescription Use (Per 21 CFR 801.109)