(182 days)
No
The description focuses on standard physiological monitoring and signal processing without mentioning AI/ML algorithms for analysis or interpretation.
No
The device is a monitor that measures physiological signs and alerts medical personnel to out-of-limit parameters; it does not directly treat or alleviate a medical condition.
No
The device monitors vital physiological signs and parameters like SpO2, pulse rate, CO2, and respiration rate, but it is not described as diagnosing a condition or disease.
No
The device description explicitly states it is a "Multi-parameter Patient Monitor" with internal circuitry, a CPU, and a screen, indicating it is a hardware device that utilizes software for processing and display. It also mentions the use of accessories and sensors that transfer physical parameters into electrical signals.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The Vital Signs Monitor described here is used for non-invasive continuous monitoring of physiological signs on the patient (SpO2, pulse rate, CO2, respiration rate).
- The device description focuses on sensors that transfer physical parameters into electrical signals. This is characteristic of devices that measure physiological functions directly, not analyze biological samples.
- The intended use is for monitoring vital signs of the patient in a hospital environment. This aligns with the function of a patient monitor, not an IVD.
Therefore, the Vital Signs Monitor described is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
Product codes (comma separated list FDA assigned to the subject device)
DQA, CCK
Device Description
PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric usage
Intended User / Care Setting
Used only under regular supervision of clinical personnel in a hospital environment.
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)
The PC 900A has undergone Third Party safety testing in accordance with IEC standards and completed performance testing in accordance with IEC standards.
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.
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
MAR 3 0 2010
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and letters. The sequence appears to be K093016. The numbers and letters are written in a dark ink, and the background is white. The handwriting is somewhat stylized, with some characters slightly distorted.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
ﮧ
Date: September 6, 2009
- Company and Correspondent making the submission:
Name - Shenzhen Creative Industry Co., Ltd.
Address - 2/F, Block 3, Nanyou Tian'an Industry Town,
Nanshan District, Shenzhen City
Shenzhen, GD P. R. China
Telephone - +86 755 2643 3514
Fax - +86-755-2643 5433
Contact - Wang Jia
Email – jia-wang@163.com
2. Device :
Trade/proprietary name: Vital Signs Monitor, Model PC-900A
: Oximeter Common Name
400 analyzer, gas, carbon-dioxide, gaseous-p
Classification Name : 21CFR870.2700, Oximeter, DQA
21CFR868.1400, 400 analyzer, gas, carbon-dioxide,
gaseous-p, CCK
Predicate Devices:
| Predicate Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| Capnostream 20 | Oridion | ||
| Capnography, | |||
| Incorporated | K060065 | Vital Signs Monitor, Model | |
| PC-900A | |||
| Vital Signs | |||
| Monitor (Model | |||
| M3B) | Edan | ||
| Instruments, | |||
| Incorporated | K083821 | Vital Signs Monitor, Model | |
| PC-900A |
1
-
Classifications Names & Citations : 21CFR 870.2700, DQA 21CFR868.1400, CCK
-
Description :
4.1 General
PC-900A vital signs monitor is a small Multi-parameter Patient Monitor, which can monitor the vital physiological parameters: Carbon Dioxide (CO2), Pulse Oxygen Saturation (SpO2), respiration and pulse rate. The accessories and the sensors will transfer the physical parameters into electrical signal, which will be collected and amplified by the circuit in the device. The specific sensors have been previously cleared by the FDA 510(k) process. (For specifics, please refer to the Description Section). After CPU analyzing and calculating, the parameters can display on the screen in a graphical way, record and/or print if necessary. The alarm will work if the parameters over the limits to take medical practitioner's attention.
-
- Indication for use :
The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate.
- Indication for use :
The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel.
-
- Comparison with predicate device: Please see next page for the comparison table.
2
| Element of
| Comparison | Subject Device | Claimed SE Device 1 | Claimed SE Device 2 |
|---|---|---|---|
| Company | Shenzhen Creative Industry Co., | ||
| Ltd. | Oridion Medical 1987 Ltd. | Edan Instruments, Inc. | |
| FDA510(K) | |||
| Number | N/A | K060065 | K083821 |
| Device Name | Vital Signs Monitor | Portable Bedside | |
| Capnograph/Pulse Oximeter | |||
| Capnostream™ 20 | Vital Signs Monitor | ||
| Model Number | PC-900A | M3B | |
| Power Supply | Battery or AC | Battery or AC | Battery or AC |
| Internal Power | |||
| Supply | rechargeable sealed lead-acid | ||
| battery, 12V 2.3AH | rechargeable Lithium-Ion battery, | ||
| 14.8V 4.4AH | rechargeable Lithium-Ion battery, | ||
| 14.8V 4.4AH | |||
| AC Power Supply | 100~250V 50/60Hz 90VA | 100~240V 50/60Hz 90VA | 100~240V 50/60Hz 45VA |
| The type of | |||
| protection against | |||
| electric shock | Class I and internally powered per | ||
| IEC 60601-1. | Class I and internally powered per | ||
| IEC 60601-1. | Class I and internally powered per | ||
| IEC 60601-1. | |||
| The degree of | |||
| protection against | |||
| electric shock | Type BF | Type BF | Type BF |
Comparison with legally marketed predicate device
33 of 738
3
| Display | Dimensions(mm) | Intended patient population | Intended Use |
|---|---|---|---|
| LED and LCD display | $360(L) \times 320(D) \times 410(H)$ | Adult, pediatric patients | The Vital Signs Monitor is designed for monitoring the vital physiological signs of the patient. It is use for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO₂ and respiration rate. |
| The Vital Signs Monitor is adaptable to adult and pediatric usage in a hospital environment. It is intended to be used only under regular supervision of clinical personnel. | |||
| TFT Display | $220 (L) x192 (D) x167 (H)$ | Adult, pediatric and neonate patients | The Capnostream2 0 is intended for CO2 and SPO2 indications. The Capnostream20 combined capnograph/pulse oximeter monitor is intended to provide professionally trained health care providers the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2 and pulse rate). It is intended for use with neonatal, pediatric and adult patients in hospitals, hospital type facilities, intra hospital moves and home environments. |
| LCD display | $173.5(L) x 189(D) x 241(H)$ | Adult, pediatric and neonate patients | The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and C02. |
| The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital environment and intra-hospital moves. | |||
| The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both. |
:
34 of 738
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4
| Nurse call function | Yes | Yes | Yes | CO₂ module | CO₂ measurement method | CO₂ measure mode | |
|---|---|---|---|---|---|---|---|
| SpO₂ | Respironics LoFlo™ EtCO2 (Side-stream) Module(K053174) and | ||||||
| CAPNOSTAT 5 EtCO2 (Main-stream) Module(K042601) | Infrared absorption method | Sidestream or Mainstream | |||||
| SpO₂ module | Creative SpO₂ module with the | ||||||
| same principle as PC-60(K063641) | |||||||
| Creative SpO₂ sensor only | Masimo SET pulse oximetry and | ||||||
| Masimo SpO₂ Sensors | Nellcor Nell-1 OXI-Max SpO₂ | ||||||
| module and Nellcor sensor | Microstream EtCO2 Module | Microstream® non-dispersive infrared (NDIR) spectroscopy | Sidestream | ||||
| SpO₂ measure | |||||||
| range | 70%~99% | 1%~100% | 1%~100% | Respironics LoFlo™ EtCO2 (Side-stream) Module and Repironics | |||
| CAPNOSTAT 5 EtCO2 (Main-stream) Module | Infrared absorption method | Sidestream or Mainstream | |||||
| Accuracy of SpO₂ | Adult and Pediatric: | ||||||
| $\pm$ 3% (during 70%~99%) | |||||||
| Undefined (during 0~70%) | Adult and Pediatric: | ||||||
| $\pm$ 2% (during 70%~100%) | |||||||
| Neonate: | |||||||
| $\pm$ 3% (during 70%~100%) | |||||||
| Undefined (during 0~70%) | Adult and Pediatric: | ||||||
| $\pm$ 2% (during 70%-100%) | |||||||
| Neonate: | |||||||
| $\pm$ 3% (during 70%-100%) | |||||||
| Undefined (during 0~70%) | Measuring parameters | CO₂ Response Time | Units | ||||
| Alarm of SpO₂ | High and lower alarms. | ||||||
| The limits are adjustable. | High and lower alarms. | ||||||
| The limits are adjustable. | The limit is adjustable. | EtCO₂, InsCO₂ and Respiration Rate | Sidestream: |