(28 days)
The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse, or medical specialist.
The proposed vital signs monitor is a modification of a previously cleared Colin Press Mate Advantage (K973637). The proposed model, HBP-2070, measures and monitors: Noninvasive blood pressure (NIBP), Oxygen saturation (SpO2), ECG, Respiration rate (RR), Heart Rate (HR), and Temperature.
1. Table of acceptance criteria and the reported device performance:
The provided document is a 510(k) premarket notification for the Omron HBP-2070, which aims to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are not explicitly stated as performance targets, but rather as alignment with or improvements over the predicate device's specifications. The "reported device performance" is the HBP-2070's specifications.
| Measurement Parameter | Acceptance Criteria (Predicate Device K973637 or other listed predicate) | Reported Device Performance (HBP-2070 Series) |
|---|---|---|
| NIBP | ||
| Measurement method | Oscillometric method | same as predicate device |
| Patient target | Adult, Pediatric, Neonatal | same as predicate device |
| SYS - Adult | 60 - 250 mmHg | same as predicate device |
| SYS - Pediatric / Neonatal | 40 - 120 mmHg | same as predicate device |
| MAP - Adult | 45 -- 235 mmHg | Uses another NIBP module - M3500 (used in HBP-T105 (K071645)) |
| MAP - Pediatric / Neonatal | 30 - 100 mmHg | Uses another NIBP module - M3500 (used in HBP-T105 (K071645)) |
| DIA - Adult | 40 - 200 mmHg | Uses another NIBP module - M3500 (used in HBP-T105 (K071645)) |
| DIA - Pediatric / Neonatal | 20 - 90 mmHg | Uses another NIBP module - M3500 (used in HBP-T105 (K071645)) |
| Pressure display range | 10 - 300 mmHg | 0-300mmHg (Adult), 0-150mmHg (Neo) |
| Accuracy of pressure indicator | Within ±3 mmHg or 1 % of reading | Within ±3 mmHg |
| Pressure sensor | Semiconductor pressure sensor | same as predicate device |
| Pulse rate range | 40 to 240 beats/min. | same as predicate device |
| Accuracy of pulse rate | Within ±2 beats/min or ±2% of reading | same as predicate device |
| Inflation method | DC Rolling diaphragm pump | same as predicate device |
| Deflation method | Dynamic linear deflation | same as predicate device |
| Shock protection | Type BF(Defibrillator protected) | Type CF(Defibrillator protected) |
| ECG | ||
| HR measure range | 30 - 300 BPM | 30 - 300BPM |
| HR Accuracy | ±3 BPM or ±5% whichever is greater | ±1 BPM or ±1% whichever is greater |
| Lead | 3 / 5 Lead | same as predicate device |
| Lead off detection | Detected and displayed | same as predicate device |
| Input dynamic range | ±5mV AC, ±300mV DC | same as predicate device |
| Voltage range | ±0.5mV ~ ±5mV | same as predicate device |
| Signal Width | 40 ms ~ 120 ms (Q to S) | same as predicate device |
| Frequency response Low Extend | 0.05 Hz - 40 Hz | 0.5 Hz - 30 Hz (Monitor), 0.32 Hz - 40 Hz, 0.5 Hz - 40 Hz |
| Respiration rejection | None | 1 Hz - 40 Hz |
| ECG size | ×1/2, ×1, ×2, ×4 | ×1/4, ×1/2, ×1.×1.5, ×2 |
| Display Sweep Size | 6.25, 12.5, 25 mm/sec | 12.5, 25, 50 mm/sec |
| Shock protection | Type CF(Defibrillator protected) | same as predicate device |
| RESP | ||
| Measurement method | Trans-thoracic impedance | same as predicate device |
| Range | 3 to 150 breaths/min | 3 to 120 breaths/min |
| Accuracy of pulse rate | ±3 breaths/min | same as predicate device |
| Lead | RA to LL | RA to LA |
| Display Sweep Size | 6.25, 12.5, 25 mm/sec | same as predicate device |
| Shock protection | Type CF(Defibrillator protected) | same as predicate device |
| SpO2 | ||
| SpO2 module | Nellcor MP-203 | Nellcor NELL-3 (used in Omron BP-S510 (K063690)) |
| Measurement method | 2 wave length pulse wave type | same as predicate device |
| SpO2 display range | 50 - 100 % | 1 - 100 % |
| Accuracy (Adult) | 70% - 100% ± 2digits | same as predicate device |
| Accuracy (Pediatric / Neonate) | 70% - 100% ± 3digits | same as predicate device |
| Display Sweep Size | 12.5, 25, 50 mm/sec | same as predicate device |
| Pulse rate display range | 20 - 250 beats/min | same as predicate device |
| Accuracy of pulse rate | Within ± 3 beats/min | same as predicate device |
| Shock protection | Type BF(Defibrillator protected) | Type CF(Defibrillator protected) |
| TEMP | ||
| Measurement method | Thermistor probe YSI 400 or 700 | same as predicate device |
| Parameter Displayed | Temp (1ch) | TI (1ch) |
| Display range | 15.0 - 45.0°C | same as predicate device |
| Accuracy | ± 0.1 °C (25 °C to 45 °C), ± 0.2 °C (15 °C to less than 25 °C) | ± 0.1 °C |
| Scale | Selectable from C to F | same as predicate device |
| Probe Accuracy | ± 0.1 °C | same as predicate device |
| Shock protection | Type BF(Defibrillator protected) | Type CF(Defibrillator protected) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a 510(k) premarket notification for a medical device (Omron HBP-2070 vital signs monitor). It primarily relies on demonstrating substantial equivalence to previously cleared predicate devices (K973637, K071645, K063690).
The document does not describe a specific clinical study with a test set of patient data for the HBP-2070 itself. Instead, it justifies its performance by stating that key modules (NIBP, SpO2) utilize components and/or algorithms from predicate devices that have already been cleared. For example:
- "Clange in the NIBP module to M3500 which has been used in our predicate HBP- T105 . (K071645)."
- "Change in the SpO2 module to Nell 3 which has been used and cleared in our predicate . BPS S510 (K063690)"
Therefore, there is no explicit mention of sample sizes for a new "test set" for the HBP-2070, nor data provenance (country of origin, retrospective/prospective) because the primary evidence for safety and effectiveness is through comparison to existing device approvals. Any performance data would have been generated and reviewed for the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As explained above, this submission relies on substantial equivalence to predicate devices, not on a new clinical study with expert-established ground truth for the HBP-2070.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no new test set described that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Omron HBP-2070 is a vital signs monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not explicitly stated as a standalone "algorithm only" study in the context of a software-based AI algorithm evaluation. However, the performance specifications listed in the table (e.g., accuracy of pressure indicator, HR accuracy, SpO2 accuracy, temperature accuracy) represent the device's intrinsic measurement capabilities, which are essentially "standalone" in their function to provide readings. These specifications are compared to those of the predicate devices. The "Software updates" mentioned are part of the overall device functionality, but not presented as a distinct AI algorithm subjected to separate standalone performance testing in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the "ground truth" establishment for the predicate devices' evaluations, as it focuses on the HBP-2070's substantial equivalence to those devices. Typically, for vital signs monitors, ground truth for accuracy studies (which would have been conducted for the predicate devices) involves:
- NIBP: Invasive arterial blood pressure measurements (intra-arterial catheter) or simultaneous readings from another highly accurate, validated NIBP device.
- ECG/Heart Rate: Simultaneously recorded reference ECGs validated by cardiologists or a highly accurate reference heart rate counter.
- SpO2: Co-oximetry measurements from arterial blood samples.
- Respiration Rate: Visual counting by experts or capnography.
- Temperature: Calibrated reference thermometers.
The specific "ground truth" methodologies would have been part of the original 510(k) submissions for the predicate devices.
8. The sample size for the training set
Not applicable. This device is not described as an AI/ML algorithm that undergoes a distinct "training set" process. Its performance is based on established engineering principles and components from already cleared devices.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" for an AI/ML algorithm in this submission.
{0}------------------------------------------------
Omron HBP-2070
Non-Confidential Summary of Safety and Effectiveness
| Page 1 of 523-Sep-08 | OCT 22 2008 | ||
|---|---|---|---|
| Omron Healthcare, Inc.1200 Lakeside Dr.Bannockburn, IL 60015 | Tel - 847-247-5609Fax - 847-680-6269 | ||
| Official Contact: | Ranndy Kellogg - VP Marketing & Product Development | ||
| Proprietary or Trade Name: | HBP-2070 | ||
| Common/Usual Name: | Monitor, Physiological, Patient (without arrhythmia detection oralarms) | ||
| Classification Name/Code: | DXN - System, Measurement, Blood-pressure, Non-invasive | ||
| Device: | Model - HBP-2070 | ||
| Predicate Devices: | Omron - Press-Mate Advantage - K973637 | ||
| Patient Population: | Adult, Pediatric, Neonate | ||
| Environment of Use: | All areas of a hospital and hospital-type facilities | ||
| Contraindications: | None | ||
| Summary of substantial equivalence | |||
| Indications for Use | Monitors: | ||
| Non-invasive blood pressure (NIBP), | same as predicate device | ||
| Oxygen saturation(SpO2), | |||
| ECG, | |||
| Respiration rate, | |||
| Heart rate (HR), and | |||
| Body Temperature (Temp) | |||
| Patient Population | Adult, Pediatric or Neonatal | ||
| Environment of use | All areas of a hospital and hospital-type | ||
| facilities | |||
| Physical Characteristics | |||
| Dimensions (mm) | 172 (W) × 216 (D) × 228 (H) mm | 257 (W) × 210 (D) × 152 (H) mm | |
| Weight | Approximately 6.0kg(including internal battery) | Approximately 3.5kg(including internal battery) | |
| Environmental Condition | |||
| Operating conditions | 0 to 40 °C,30 to 85 %RH non-condensing | 5 to 40 °C,30 to 85 %RH non-condensing | |
| Storage conditions | -20 to 70 °C,10 to 100 %RH non-condensing | -20 to 60 °C,10 to 95 %RH non-condensing | |
| Display | |||
| Screen size | 5.6inch TFT color LCD | 7inch TFT color LCD | |
| Resolution | 400 × 320 pixel | 800 × 480 pixel | |
| Number of Traces | 1 or 2 waveforms | 1 or 3 waveforms | |
| Electrical | |||
| Power source | AC MainsBattery (lead acid) | AC MainsBattery (Lithium ion) | |
| Power range | AC: 100-120V 50 / 60HzBattery: 12V 1.8Ah | AC: 100-240V 50 / 60HzBattery: 11.1V 2.4Ah or 7.2Ah | |
| Battery operation time | A battery typically provides operatingtime of 30 minutes when fully chargedwith no printing, no externalcommunication, no audible alarm soundand one NIBP measurement per 5minutes at 25°C. | A battery typically provides operatingtime of 1 hour and 6 hour when fullycharged with no printing, no externalcommunication, no audible alarm soundand one NIBP measurement per 10minutes at 25°C. |
Device Description:
The proposed vital signs monitor is a modification of a previously cleared Colin Press Mate Advantage (K973637).
The proposed model, HBP-2070, measures and monitors:
- . Noninvasive blood pressure (NIBP)
- . Oxygen saturation (SpO2)
- . ECG
- Respiration rate (RR) .
- . Heart Rate (HR), and
- Temperature .
Indications for Use:
The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in all areas of a hospital and hospital-type facilities.
Monitor users should be skilled at the level of a technician, doctor, nurse, or medical specialist.
{1}------------------------------------------------
Omron HBP-2070
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 5 23-Sep-08
{2}------------------------------------------------
Omron HBP-2070
Non-Confidential Summary of Safety and Effectiveness
Page 3 of 5 23-Sep-08 Predicate Press-Mate Advantage K973637
New Model HBP-2070 series
Recorder Type Thermal same as predicate device Resolution 8 dot/min same as predicate device 1 to 2 channels Number of Channel same as predicate device Paper width 58 min 50 mm Paper speed 6.25,25 and 50mm/sec 25 and 50mm/sec 【NIBP】 Measurement method Oscillometric method same as predicate device Patient target Adult, Pediatric, Neonatal same as predicate device SYS - Adult) 60 - 250 mmHg NIBP same as predicate device Measurement range Pediatric / Neonatal) 40 - 120 mmHg MAP - Adult) 45 -- 235 mmHg Uses another NIBP module - M3500 Pediatric / Neonatal) 30 -100 mmHg which has been used in our predicate DIA - Adult) 40 - 200 mmHg HBP-T105 (K071645) Pediatric / Neonatal) 20 -90 mmHg Pressure display range 10 - 300 mmHg 0-300mmHg ( Adult ) 0-150mmHg(Neo) Accuracy of pressure indicator Within ±3 mmHg or 1 % of reading Within ±3 mmHg Pressure sensor Semiconductor pressure sensor same as predicate device Pulse rate: 40 to 240 beats/min. Pulse rate range same as predicate device Accuracy of pulse rate Within ±2 beats/min or ±2% of reading same as predicate device DC Rolling diaphragm pump Inflation method same as predicate device Deflation method Dynamic linear deflation same as predicate device Shock protection Type BF(Defibrillator protected) Type CF(Defibrillator protected) 【EGG】 HR measure range 30 - 300 BPM 30 - 300BPM HR Accuracy ±3 BPM or ±5% whichever is greater ±1 BPM or ±1% whichever is greater Lead 3 / 5 Lead same as predicate device LeadL, J, J, aVR,aVL,aVF,V(Chest) Lead off detection Detected and displayed same as predicate device Input dynamic range ±5mV AC,±300mV DC same as predicate device Voltage range ±0.5mV ~ same as predicate device ±5mV Signal Width same as predicate device 40 ms ~ 120 ms ( Q to S ) Frequency response Low Extend same as predicate device 0.05 Hz - 40 Hz Filter None 0.5 Hz - 30 Hz Monitor 0.32 Hz - 40 Hz 0.5 Hz - 40 Hz Respiration rejection None 1 Hz - 40 Hz ECG size ×1/2,×1,×2,×4 ×1/4,×1/2,×1.×1.5,×2 Display Sweep Size 6.25.12.5.25 mm/sec 12.5,25,50 mm/sec Shock protection
Type CF(Defibrillator protected)
same as predicate device
{3}------------------------------------------------
Koszá 12
【RESP】
Omron HBP-2070
Non-Confidential Summary of Safety and Effectiveness
Page 4 of 5 23-Sep-08
Predicate Press-Mate Advantage K973637
New Model HBP-2070 series
| Measurement methodRangeAccuracy of pulse rateLeadDisplay Sweep SizeShock protection【SpO2】 | Trans-thoracic impedance3 to 150 breaths/min$\pm$ 3 breaths/minRA to LL6.25, 12.5, 25 mm/secType CF(Defibrillator protected) | same as predicate device3 to 120 breaths/minsame as predicate deviceRA to LAsame as predicate devicesame as predicate device |
|---|---|---|
| SpO2 module | Nellcor MP-203 | Nellcor NELL-3Predicate Omron BP-S510 (K063690) |
| Measurement method | 2 wave length pulse wave type | same as predicate device |
| SpO2 display range | 50 - 100 % | 1 - 100 % |
| Accuracy | Adult - 70% - 100% $\pm$ 2digits1% - 69% unspecifiedPediatric / Neonate70% - 100% $\pm$ 3digits1% - 69% unspecified | same as predicate device |
| Display Sweep Size | 12.5,25,50 mm/sec | same as predicate device |
| Pulse rate display range | 20 - 250 beats/min | same as predicate device |
| Accuracy of pulse rateShock protection【TEMP】 | Within $\pm$ 3 beats/minType BF(Defibrillator protected) | same as predicate deviceType CF(Defibrillator protected) |
| Measurement method | Thermistor probe YSI 400 or 700 | same as predicate device |
| Parameter Displayed | Temp ( 1ch ) | TI ( 1ch ) |
| display range | 15.0 - 45.0°C | same as predicate device |
| Accuracy | $\pm$ 0.1 °C (25 °C to 45 °C )$\pm$ 0.2 °C ( 15 °C to less than 25 °C ) | $\pm$ 0.1 °C |
| Scale | Selectable from C to F | same as predicate device |
| Probe Accuracy | $\pm$ 0.1 °C | same as predicate device |
| Shock protection | Type BF(Defibrillator protected) | Type CF(Defibrillator protected) |
The base modifications are:
- Change in the SpO2 module to Nell 3 which has been used and cleared in our predicate . BPS S510 (K063690)
- Clange in the NIBP module to M3500 which has been used in our predicate HBP- T105 . (K071645).
- . Software updates
{4}------------------------------------------------
Non-Confidential Summary of Safety and Effectiveness Page 5 of 5 23-Sep-08
Differences Between Other Legally Marketed Predicate Devices
The Omron HBP-2070 vital signs monitor is viewed as substantially equivalent to the predicate device because:
Indications -
- Identical to predicate K973637 .
Technology -
- Identical algorithms to predicate K071645 .
Materials -
- The materials in patient contact are identical to predicate devices as listed in Section 15. .
Environment of Use -
- Identical to predicate K973637 .
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
{5}------------------------------------------------
Public Health Service
Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle emblem.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 2008
Omron Healthcare, Inc. c/o Mr. Paul Dryden ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134-2958
Re: K082812
Trade/Device Name: Model HBP-2070 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Codes: MWI, DXN, DQA, FLL Dated: September 23, 2008 Received: September 24, 2008
Dear Mr. Dryden:
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. 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.
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
{6}------------------------------------------------
Page 2 -Mr. Paul Dryden
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 Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use Statement
Page 1 of 1
510(k) Number: KOS Z& 2 (To be assigned)
HBP-2070 Device Name:
Indications for Use:
The HBP-2070 is intended to be used to monitor electrocardiography (ECG),heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressure) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR) temperature (Temp) for adult, pediatric, and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse, or medical specialist.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Atuthe for B Zuckerman
sion of Cardiovascular Devices
510(k) Number K082812
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).