(100 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ultrasonic measurements and visualization.
No
The device is described as a diagnostic tool used for measurement and visualization, not for treating any condition.
Yes
The device is described as an "ophthalmic ultrasound system" used for "Axial Length measurement," "Implanted IOL power calculation," and "Visualization of the interior of the eye and the orbit by A and B scans," which are all diagnostic functions. Furthermore, it explicitly states "Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment" in the performance studies section.
No
The device description explicitly states it is a "high definition multifunction ophthalmic ultrasound system" and the performance studies section mentions "hardware and software validation activities were performed," indicating it includes hardware components.
Based on the provided information, the Quantel Medical ABSOLU is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the ABSOLU is used for measurements and visualization of the eye and orbit directly on the patient, not on samples taken from the patient.
- The functions described (axial length measurement, IOL power calculation, A and B scans) are all performed in vivo (within the living body). IVD tests are performed in vitro (outside the living body).
The ABSOLU is a medical device used for ophthalmic ultrasound, which is a form of medical imaging and measurement performed directly on the patient.
N/A
Intended Use / Indications for Use
The Quantel Medical ABSOLU is intended to be used for:
-Axial Length measurement of the eye by ultrasonic means;
-Implanted IOL power calculation, using the Axial Length measurement;
- Visualization of the interior of the eye and the orbit by A and B scans.
Product codes (comma separated list FDA assigned to the subject device)
IYO
Device Description
The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:
- -Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the axial length measurements; -
- Visualization of the interior of the eve and the orbit by A and B scans. -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Eye, orbit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
intended to be used by trained medical personnel. The use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic.
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)
Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:
- AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.
The changes to the physical characteristics were supported by electrical safety and electromagnetic compatibility testing. The changes to the user interface were shown to be in compliance with IEC 60601-1-6. The changes to the B-scan probes are in compliance with IEC 60601-2-37. Ultrasound testing was performed using Track 1.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Quantel Medical % Ms. Maureen O'connell President O'Connell Regulatory Consultants, Inc. 44 Oak Street STONEHAM MA 02180
March 20, 2019
Re: K183414
Trade/Device Name: ABSOLU® Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO Dated: February 27, 2019 Received: February 28, 2019
Dear Ms. O'connell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183414
Device Name ABSOLU®
Indications for Use (Describe)
The Quantel Medical ABSOLU is intended to be used for:
-Axial Length measurement of the eye by ultrasonic means;
-Implanted IOL power calculation, using the Axial Length measurement;
- Visualization of the interior of the eye and the orbit by A and B scans.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Page : 2/7
System: Absolu
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | (A-mode) | |||||
| P | ||||||||
| Fetal | ||||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Abdominal | |||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
4
System: Absolu
15 MHz B-scan Probe (ref model number B1) Transducer :
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | ||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
5
System: Absolu
11 MHz Biometry Probe (ref model number : TP-01-b/ TP-02-las) Transducer :
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) B/M | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | (A-mode) | |||||||
| P | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-Skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
6
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System: Absolu
Transducer : Standardized A Probe (ref model number : STD-A : (8 MHz)
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | (A-mode) | ||||||
| P | ||||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
7
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System: Absolu
Transducer : 50 MHz Linear Probe (ref model number : Lin 50 : (50 MHz)
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | | Mode of Operation | | | | | | Other*
(Specify) |
|------------------------------|------------------------------------|-------------------|---|-----|-----|------------------|---------------------------|---------------------|
| General
(Track 1
Only) | Specific
(Tracks 1 & 3) | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) B/M | |
| Ophthalmic | Ophthalmic | P | | | | | | |
| | Fetal | | | | | | | |
| | Abdominal | | | | | | | |
| | Intra-operative (Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| | Small organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph (non-Card.) | | | | | | | |
| Fetal
Imaging &
Other | Musculo-skeletal
(Conventional) | | | | | | | |
| | Musculo-Skeletal (Superficial) | | | | | | | |
| | Intravascular | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | |
| | Trans-esoph (Cardiac) | | | | | | | |
| Cardiac | Intra-cardiac | | | | | | | |
| | Other (Specify) | | | | | | | |
| | | | | | | | | |
| Peripheral
Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
8
Page : 7/7
System: Absolu
Transducer : B 20MHz -5A B-SCAN PROBE (ref model number : B20-5A: (20 MHz)
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color | ||||||
| Doppler | Combined | |||||||||
| (Specify) B/M | Other* | |||||||||
| (Specify) | ||||||||||
| General | ||||||||||
| (Track 1 | ||||||||||
| Only) | Specific | |||||||||
| (Tracks 1 & 3) | Ophthalmic | E | ||||||||
| Fetal | ||||||||||
| Fetal | ||||||||||
| Imaging & | ||||||||||
| Other | Abdominal | |||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small organ (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph (non-Card.) | ||||||||||
| Musculo-skeletal | ||||||||||
| (Conventional) | ||||||||||
| Musculo-Skeletal (Superficial) | ||||||||||
| Intravascular | ||||||||||
| Other (Specify) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Cardiac | Trans-esoph (Cardiac) | |||||||||
| Intra-cardiac | ||||||||||
| Other (Specify) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
9
510(k) SUMMARY
Quantel Medical ABSOLU®
510(k) Owner
Quantel Medical 11 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France 33 04 73 745 732 Phone: Contact Person: Bruno Pagès
Submission Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 Phone: 978-207-1245
Date Prepared: February 26, 2019
Trade Name of Device ABSOLU ®
Common or Usual Name
Ultrasonic Pulsed Echo Imaging system
Classification Name
Ultrasonic Pulsed Echo Imaging system; 21 C.F.R. 892.1560 Class II Product Code: IYO
Predicate Device
Quantel Medical AVISO (K051851)
Device Description
The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use:
- -Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the axial length measurements; -
- Visualization of the interior of the eve and the orbit by A and B scans. -
10
The following probes are compatible with Absolu depending upon the different configurations with the panel of probes chosen:
| Probe | ABSolu B | ABSolu S | ABSolu B
with a B 20
annular option | ABSolu S
with a B 20
annular option |
|----------------------------------------------|----------|----------|-------------------------------------------|-------------------------------------------|
| Biometry A-probe | Yes | Yes | Yes | Yes |
| Biometry A-probe with a laser
aiming beam | Yes | Yes | Yes | Yes |
| Standardized A-probe | No | Yes | No | Yes |
| B15MHz probe | Yes | Yes | Yes | Yes |
| Linear 50MHz probe | Yes | Yes | Yes | Yes |
| B20MHz annular probe | No | No | Yes | Yes |
Intended Use / Indications for Use
The Ouantel Medical ABSOLU is intended to be used for:
- Axial Length measurement of the eye by ultrasonic means;
- Implanted IOL power calculation, using the Axial Length measurement: ●
- . Visualization of the interior of the eve and the orbit by A and B scans.
Substantial Equivalence
Quantel Medical believes that the ABSOLU ® described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device, the Quantel Medical AVISO cleared in K051851. Yes, the predicate device for ABSOLU® is AVISO cleared in K051851.
-
- Do the devices have the same intended use?
Yes, the indications for use statement for the ABSOLU® is exactly the same as the indications for use statement for the predicate device. Additionally, both of the devices are prescription devices which are intended to be used by trained medical personnel. The use of the different parameters of the ABSOLU® and the predicate device are under control of the physician for the different phases of the diagnostic. Therefore, the ABSOLU® has the same intended use as the identified predicate device and may be found to be substantially equivalent to the predicate device.
- Do the devices have the same intended use?
-
- Does the new device have the same technological characteristics?
The ABSOLU ® has minor technological differences compared to the predicate device, which is a previous version of the same device. The technical differences are the following:
- Does the new device have the same technological characteristics?
-
Physical Characteristics: revised dimensions and cosmetics. Re-design of the device ● to be more compact.
11
- User Interface is more intuitive, divided into 4 sub-sections (general set-up, patient's ● management, exams and edition report (s)).
- A modification of the B-scan probe (20 MHz) technology. The new annular ● technology offers the opportunity to increase the depth of field by 70%. This improvement permits simultaneous examination of pathologies of the vitreous, the retina and the orbit without compromising on image quality.
- A modification of the B-scan probe (15 MHz) technology. The transducer frequency ● of the B-scan probe has been increased from 10 MHz for the cleared Aviso to 15 MHz for the new version. This variation of frequency does not affect the safety or performance of the device. The new 15 MHz probe has a superior resolution and thus may allow more favorable diagnostics. The focal point has changed from 25 mm to 24 mm, which is not considered significant because the target is to focus in the retina (which is about 24 mm). The measurement accuracy has also been improved, due to the increase of the frequency.
- The Lin 25 probe has been removed in the ABSOLU. This probe is no longer ● required.
- General Software: the software has been revised to accommodate the other device changes listed here.
Performance data is available to support the technological changes. The changes to the physical characteristics were supported by electrical safety and electromagnetic compatibility testing. The changes to the user interface were shown to be in compliance with IEC 60601-1-6. The changes to the B-scan probes are in compliance with IEC 60601-2-37. Ultrasound testing was performed using Track 1.
Therefore, in summary, the new device has the same indications for use and similar technological characteristics to the predicate device and is therefore, substantially equivalent. Performance data support substantial equivalence of the different technological characteristics.
Performance Data
Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:
- AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 Medical ● electrical equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment-Part 1-2: General requirements for ● basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General . requirements for safety-Collateral Standard Usability
12
- IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.