(261 days)
The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).
The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Penrith Elettra Diagnostic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary (K100598) is a premarket notification for a diagnostic ultrasound system. For this type of device, the primary "acceptance criteria" for clearance through the 510(k) pathway is demonstrating substantial equivalence to a predicate device. This means the device is as safe and effective as a legally marketed device.
Therefore, the acceptance criteria are implicit:
- The device must perform in a manner substantially equivalent to predicate devices.
- The device must meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning, disinfection, sterilization, thermal, electrical, mechanical safety, and electromagnetic compatibility.
- All claimed indications for use must be covered by the predicate devices.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: | "The Penrith Elettra system and transducers function in a manner that is substantially equivalent to the previously cleared devices: Acuson Sequoia (K022567), the Acuson Cypress (K052331), and the Philips Avalon CTS (K023931)." |
| Functional Equivalence (Imaging & Fluid Flow) | "[Elettra and predicate devices] transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. The Elettra and the predicate devices share basic scanning modalities." |
| Measurement Capabilities | "Some or all predicate device systems allow for measurements of structures and flow, and calculations." (The Elettra is implied to have comparable capabilities given the claim of substantial equivalence and shared modalities.) |
| Acoustic Output Compliance (Track 3 method) | "Some or all predicate devices and the Elettra follow the Track 3 method for acoustic output." |
| Biocompatibility | "Patient contact materials used in the Elettra are used in equivalent formulations in the predicate devices." |
| Safety & Compliance with Standards | "The Penrith Elettra has been evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility. It has been found to conform with applicable medical device safety standards." |
| Indications for Use | "All indications for use claimed for the Elettra are cleared indications found on some or all of the predicate devices." (Detailed in pages 4-8, with 'N' (New) referring to new to that transducer, but equivalent to modes on predicate devices). |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) premarket notification for an ultrasound system, which primarily relies on demonstrating substantial equivalence to predicate devices, rather than a clinical study comparing the device to a "gold standard" or a control group.
- No specific "test set" sample size is mentioned in the document for performance comparison in a clinical trial sense. The evaluation for substantial equivalence is based on technical, functional, and safety comparisons to already cleared devices.
- Data provenance: Not applicable in the context of a prospective clinical "test set" as none is detailed. The performance claims are backed by adherence to standards and comparison of specifications to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The document does not describe a clinical study involving a test set with expert-established ground truth. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices and the adherence to relevant medical device standards.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set and no expert adjudication process are described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document does not mention any MRMC comparative effectiveness study. This type of study is more common for AI/CADe devices that assist human readers in interpretation. The Penrith Elettra is a diagnostic imaging system itself, not an AI interpretation tool.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop) Was Done
- Not applicable. The Penrith Elettra is a diagnostic ultrasound system, not an AI algorithm. Its "standalone performance" is its ability to generate images and perform measurements, which is assessed through technical evaluation and comparison to predicate devices, rather than a specific algorithm-only study. The document states it was "evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility."
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" is primarily:
- The established safety and effectiveness of the identified predicate devices (Acuson Sequoia K022567, Acuson Cypress K052331, Philips Avalon CTS K023931).
- Compliance with recognized medical device safety and performance standards (e.g., Track 3 method for acoustic output, electrical/physical safety standards).
8. The Sample Size for the Training Set
- Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As no training set is involved for this device, there is no ground truth establishment for a training set.
In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. It demonstrates safety and effectiveness by establishing substantial equivalence to existing, legally marketed predicate devices through technical comparisons, adherence to standards, and matching indications for use. It does not involve a clinical study with specific test sets, expert ground truth development, or AI algorithm performance evaluation the way a more modern AI/CADe submission might.
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K/00598
Summary of Safety and Effectiveness
NOV 1 9 2010
This summary of 510(k) safety and effectiveness information is submitted as a part of this Premarket Notification in accordance with the requirements of the Safe Medical Devices Act of 1990 as implemented in 21 CFR 807.92.
1) Submitter's information:
Penrith Corporation 5170 Campus Drive Suite 2 Plymouth Meeting, PA 19462 USA
Corresponding official: Email: Telephone: Fax:
Lawrence Engle lengle@penrithcorp.com 610 834 1220 610 834 1220
Date Summary Prepared:
February 10, 2010
2) Device Information
The proprietary name of the device is the Penrith Elettra Diagnostic Ultrasound System.
The Elettra is classified as follows:
90 IYN Ultrasonic Pulsed Doppler Imaging System
Ultrasonic Pulsed Echo Imaging System 90 IYO
90 ITX Diagnostic Ultrasound Transducer
The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.
The Penrith Elettra is intended to be used by a qualified physician for diagnostic imaging or fluid flow analysis of the human body including: Fetal,
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Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), and Musculoskeletal (Superficial).
The Company believes that the Penrith Elettra is substantially equivalent to the Acuson Sequoia, K022567, the Acuson Cypress K052331, and the Philips Avalon CTS, K023931.
The Penrith Elettra system and transducers function in a manner that is substantially equivalent to the previously cleared devices: Predicate device systems and the Elettra transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. The Elettra and the predicate devices share basic scanning modalities. Some or all predicate device systems allow for measurements of structures and flow, and calculations. Some or all predicate devices and the Elettra follow the Track 3 method for acoustic output. Patient contact materials used in the Elettra are used in equivalent formulations in the predicate devices. All indications for use claimed for the Elettra are cleared indications found on some or all of the predicate devices. The Elettra ultrasound transducer may be used in a wireless configuration or in a cabled configuration. The Elettra and the predicate devices have been designed and manufactured under comparable electrical and physical safety standards.
The Penrith Elettra has been evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility. It has been found to conform with applicable medical device safety standards.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Penrith Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Servies, LLC 1394 25th Street NW BUFFALO MN 55313
NOV 1 9 2010
Re: K100598
Trade/Device Name: Penrith Elettra Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 18, 2010 Received: October 19, 2010
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 Penrith Elettra Ultrasound System, as described in your premarket notification:
Transducer Model Number
L8-3 Linear L12-5 Linear C5-2 Curvilinear
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
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can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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 (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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter. please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
David C. Rainer, Ph.D.
David G. Brown, Ph.D. Acting Director . Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Section 1.3 Indications for Use
NOV 1 9 2010
The Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial). See Indications for Use Forms below. The following tables provide details regarding clinical applications and modes of operation for the system and individual transducers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100598
. .
Page 1 of 5
יי
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510(k) Number (if known): K100598
Penrith Elettra Ultrasound System
Indications for Use:
Device Name:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
Indications for Use.
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)Note 2 | Other: HarmonicImaging | ||
| Opthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative Note 1 | N | N | N | ||||||||
| Intraoperative Neurological | N | N | N | ||||||||
| Pediatric | N | N | N | ||||||||
| Small Organ Note 3 | N | N | N | ||||||||
| Neonatal Cephalic | N | N | N | ||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | ||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | N | N | N | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | N | N | N | ||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||||
| Other |
N: New P: Previously Cleared Blank: Not Claimed
Note 1: for example: cardiac
Note 2: B mode and PWD mode or Color Doppler and PW mode
Note 3: for example: breast, testes, thyroid, penis
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use _ (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100598
Page 2 of 5
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510(k) Number (if known): K100598
Device Name: L8-3 Linear Transducer for use with
Penrith Elettra Ultrasound System
Indications for Use:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)Note 2 | Other: HarmonicImaging | ||
| Opthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative Note 1 | N | N | N | ||||||||
| Intraoperative Neurological | N | N | N | ||||||||
| Pediatric | N | N | N | ||||||||
| Small Organ Note 3 | N | N | N | ||||||||
| Neonatal Cephalic | N | N | N | ||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | ||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vessel | N | N | N | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal Conventional | N | N | N | ||||||||
| Musculo-skeletal Superficial | N | N | N | ||||||||
| Other |
N: New P: Previously Cleared Blank: Not Claimed
Note 1: for example: cardiac
Note 2: B mode and PWD mode or Color Doppler and PW mode
Note 3: for example: breast, testes, thyroid, penis
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR |
|---|---|
| --------------------------------------------------- | -------- |
Over-the-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100598
Page 3 of 5
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510(k) Number (if known): K100598
Device Name:
L12-5 Linear Transducer for use with Penrith Elettra Ultrasound System
Indications for Use:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)Note 2 | Other: HarmonicImaging | |
| Opthalmic | ||||||||||
| Fetal | N | N | N | |||||||
| Abdominal | N | N | N | |||||||
| Intraoperative Note 1 | N | N | N | |||||||
| Intraoperative Neurological | N | N | N | |||||||
| Pediatric | N | N | N | |||||||
| Small Organ Note 3 | N | N | N | |||||||
| Neonatal Cephalic | N | N | N | |||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | |||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | N | N | N | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | N | N | |||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Other |
N: New P: Previously Cleared Blank: Not Claimed
Note 1: for example: cardiac
Note 2: B mode and PWD mode or Color Doppler and PW mode
Note 3: for example: breast, testes, thyroid, penis
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR |
|---|---|
| --------------------------------------------------- | -------- |
Over-the-Counter Use (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100598
Page 4 of 5
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510(k) Number (if known): K100598
Device Name:
C5-2 Curvilinear Transducer for use with Penrith Elettra Ultrasound System
Indications for Use:
Diagnostic Imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify)Note 2 | Other: HarmonicImaging | |
| Opthalmic | ||||||||||
| Fetal | N | N | N | . | ||||||
| Abdominal | N | N | N | |||||||
| Intraoperative Note 1 | N | N | N | |||||||
| Intraoperative Neurological | N | N | N | |||||||
| Pediatric | N | N | N | |||||||
| Small Organ Note 3 | N | N | N | |||||||
| Neonatal Cephalic | N | N | N | |||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | |||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vessel | N | N | N | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | N | N | N | |||||||
| Musculo-skeletal Superficial | N | N | N | |||||||
| Other |
N: New P: Previously Cleared Blank: Not Claimed
Note 1: for example: cardiac
Note 2: B mode and PWD mode or Color Doppler and PW mode
Note 3: for example: breast, testes, thyroid, penis
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|
| --------------------------------------------------- | -------- | ------------------------------------------------ |
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K100598
Page 5 of 5
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.