(17 days)
Not Found
No
The document describes standard ultrasound functionalities, measurements, and guidance features without mentioning AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device's intended use is for diagnostic ultrasound imaging and fluid flow analysis, not for treating any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The predicate device is also a diagnostic ultrasound system.
No
The device description explicitly mentions "Transducers are linear and convex arrays and mechanical sector" and "All transducers used together with 1101 are Track 3 transducers." Transducers are hardware components essential for ultrasound imaging, indicating this is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that is used to visualize structures and processes within the living body, not to analyze samples taken from the body.
- Device Description: The description details scanning modes, measurements, calculations, and guidance for procedures performed on the patient (biopsy/puncture needles). This aligns with in-vivo diagnostic imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.
IVD devices are designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is used for direct imaging and analysis of the body itself.
N/A
Intended Use / Indications for Use
"Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation |
|---|---|
| Fetal | B, M, Combined (B+M) |
| Abdominal | B, M, Combined (B+M) |
| Intraoperative (specify) | B, M, Combined (B+M) |
| Intraoperative Neurological | B, M, Combined (B+M) |
| Pediatric | B, M, Combined (B+M) |
| Small Organ (specify) | B, M, Combined (B+M) |
| Cardiac | B, M, Combined (B+M) |
| Transrectal | B, M, Combined (B+M) |
| Transvaginal | B, M, Combined (B+M) |
| Musculo-skeletal Conventional | B, M, Combined (B+M) |
| Musculo-skeletal Superficial | B, M, Combined (B+M) |
Additional Comments: Intraoperative: Breast, liver, pancreas, biliary system Small Organ: Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes"
Product codes (comma separated list FDA assigned to the subject device)
90 IYO, ITX
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 less than or equal to 720 mW/cm squared and MI less than or equal to 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0. i.e. TI less than or equal to 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)."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Fetal, Intraoperative (Breast, liver, pancreas, biliary system), Neurosurgery, Pediatrics, Transrectal, Small organs (Breast, testis, penis, thyroid, parathyroid, salivary glands, lymph nodes), Transvaginal, Musculoskeletal (superficial, conventional)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: +45 4452 8100 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).
1
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, | |
| Intraoperative, Neurosurgery, | ||
| Pediatrics, Transrectal, Small | ||
| organs, Transvaginal, |
Musculoskeletal (superficial,
conventional) | General Radiology,
Abdominal,Intraoperative,Sma
ll parts, transcranial,OB/GYN,
Neonatal/Adult Cephalic,
Urology, Vascular,
Musculoskeletal, Superficial
Musculoskeletal, Peripheral
Vascular |
| General device description | B,M and combination modes,
Track 3 (Index display).
Measurements | B,M Color, PW, CW and
combination modes. Track 3
(Index display).
Measurements. |
| Acoustic output | Ispta ≤ 720 mW/cm² and MI ≤
1.9 (Track 3, non ophthalmic).
TI ≤ 6.0 | Not in 510(k)summary, except
that it has index display
according to Display standard. |
| General safety and
effectiveness | UL2601, CSA22.2 No 601-1,
EN60601, 93/42/EEC Medical
Devices Directive,
AIUM/NEMA Display
standard, EN/ISO 10993-1 | UL2601, CSA22.2 No 601-1,
EN60601,93/42/EEC Medical
Devices Directive,
AIUM/NEMA Display
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.
2
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
3
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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.
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)
4
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 | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | ||||||||||
| 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)
5
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*
(Specify) |
|---------------------------|------------------------------|---|-------------------|-----|-----|------------------|-----------------------|---------------------|
| General
(Track I Only) | Specific
(Tracks I & III) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | P | P | | | | P (B+M) | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal Imaging
& 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
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)
6
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 | ||||||||
| (Track I Only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Fetal Imaging | ||||||||
| & 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 | ||||||||
| 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)