(70 days)
The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
The 5MHz, 8MHz, or PPG probes are designed for peripheral vascular applications.
The nominal 5MHz probe previously submitted and approved under K090465.
The nominal 8MHz probe previously submitted and approved under K090465.
The PPG probe is intended for vascular applications to determine blood flow in digits.
The simpleABI is a diagnostic ultrasound system. The system consists of a main body and one probe. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.
The provided document is a 510(k) premarket notification letter from the FDA to Newman Medical for the simpleABI device. It primarily focuses on the substantial equivalence determination for the device and its transducers to legally marketed predicate devices.
The document does not contain information about acceptance criteria, device performance metrics, or any specific study results (including clinical or standalone performance studies) that would prove the device meets acceptance criteria. It also does not discuss sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or details on training sets.
The relevant sections of the document describe:
- Device Name: simpleABI
- Regulation Number/Name: 21 CFR 892.1540, Nonfetal ultrasonic monitor
- Regulatory Class: II
- Product Codes: JAF and ITX
- Indications for Use: "The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, cherce une values, and index results can be printed directly from the system."
- Included Transducers: 5 MHz, 8 MHz, PPG, all for Peripheral Vascular application (CWD mode for 5MHz and 8MHz, and new indication 'N' for PPG as mentioned on page 3)
Since the document does not provide the requested information regarding acceptance criteria and study data, I cannot complete the table or answer the specific questions about performance studies. The FDA 510(k) clearance process generally focuses on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics in the way a PMA approval might.
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Image /page/0/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 a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 1 2 2011
Mr. Spencer Newman President Newman Medical 42 Sherwood Ter. Ste 2 LAKE BLUFF IL 60044
Re: K110628
Trade/Device Name: simpleABI Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasonic monitor Regulatory Class: II Product Code: JAF and ITX Dated: April 12, 2011 Received: April 14, 2011
Dear Mr. Newman:
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 simpleABI, as described in your premarket notification:
Transducer Model Number
5 MHz 8MHz PPG
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Newman
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 Robert Ochs, Ph.D. at (301) 796-6661.
Sincerely Yours.
Mary S. Pastel
Mary S. Pastel, Sc.D. 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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Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
TBD
Device Name:
simpleABI
Indications for Use:
The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is (1997) na p plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has enterect the appropriate pressure values read from the handheld aneroid. Waveforms, cherce une values, and index results can be printed directly from the system.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 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)
Marys Pasts
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110628
Page 1 of 1
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Product Name: simpleABI with 5 MHz, 8 MHz, or PPG probe.
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| AbdominalIntraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: The system consists of a main body and one probe. The 5MHz, 8MHz, or PPG probes are designed for peripheral vascular applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mary S. Pahl
(Division Sign-Off)
Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K110628
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Fill out one form for each ultrasound system and each transducer.
Product Name: simpleABI 5MHz
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| AbdominalIntraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: The nominal 5MHz probe previously submitted and approved under K090465
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Prescription Use (Per 21 CFR 801.109)
Mers S. Pesta
(Division Sign-Off)
(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K116628
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Fill out one form for each ultrasound system and each transducer.
Product Name: simpleABI 8MHz
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| AbdominalIntraoperative(specify) | ||||||||||
| IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: The nominal 8MHz probe previously submitted and approved under K090465
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801,109)
Mery Slatil
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110628
Page 30 of 183
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Fill out one form for each ultrasound system and each transducer.
Product Name: simpleABI PPG
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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| AbdominalIntraoperative | ||||||||||
| (specify)IntraoperativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletalSuperficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: The PPG probe is intended for vascular applications to determine blood flow in digits.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use (Per 21 CFR 801.109)
Menn S. Patel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K K110628
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in 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.