Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer
Device Facts
| Record ID | K222652 |
|---|---|
| Device Name | Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer |
| Applicant | Cardicare Company, Ltd. |
| Product Code | DXQ · Cardiovascular |
| Decision Date | Nov 28, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1120 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
Device Story
Non-invasive, non-automated blood pressure measurement system; utilizes occluding cuff, bladder, inflation bulb, and aneroid gauge. Operates via manual auscultatory Korotkoff sounds method; requires user to manually inflate cuff and detect sounds (optionally using a stethoscope). Used in healthcare facilities or home settings by medical professionals or patients. Output is a pressure reading displayed on the aneroid manometer; assists clinicians in monitoring blood pressure levels. Single-patient use models designed to prevent cross-infection. Benefits include reliable, non-invasive blood pressure monitoring without electronic components.
Clinical Evidence
No clinical data were required to demonstrate substantial equivalence. Bench testing only, including performance testing per ISO 81060-1:2007 and biocompatibility testing (ISO 10993-5 cytotoxicity, ISO 10993-10 skin irritation and sensitization).
Technological Characteristics
Non-automated, non-sterile, reusable aneroid sphygmomanometer. Materials: Manometer (Aluminum/Zinc/ABS), Cuff (Nylon/Cotton/PVC), Bladder (PVC), Tubing (PVC). Sensing: Manual inflation/deflation via bulb and valve. Pressure range: 0-300mmHg. Accuracy: +/-3mmHg. Connectivity: None. Standards: ISO 81060-1 (performance), ISO 10993-1 (biocompatibility).
Indications for Use
Indicated for use by medical professionals or in the home to measure systolic and diastolic blood pressure in children and adults. No specific contraindications listed.
Regulatory Classification
Identification
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
Predicate Devices
- Aneroid Sphygmomanometer (K082542)
Reference Devices
- Aneroid Sphygmomanometer (K211084)
Submission Summary (Full Text)
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November 28, 2022
Cardicare Company, Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K222652
Trade/Device Name: Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 1, 2022 Received: September 1, 2022
Dear Charles Mack:
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.
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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); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
### K222652
Device Name Aneroid Sphygmomanometer Single Patient Use Aneroid Sphygmomanometer
### Indications for Use (Describe)
The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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K222652
### 510(k) SUMMARY K
| Preparation Date: | September 2, 2022 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer's Name and Address: | Cardicare Company, Ltd.<br>9 Yan An Road, Wu Shan Plaza Town, Unit<br>7003, Hangzhou City, Zhejiang Province, China<br>310002 |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Aneroid Sphygmomanometer<br>Single Patient Use Aneroid Sphygmomanometer |
| Common Name(s): | blood pressure cuff |
| Regulation Name(s): | Blood Pressure Cuff |
| Regulation Number(s): | 21CFR870.1120 |
| Product Code: | DXQ |
| Device Class: | Class II |
| Predicate Device:<br>Reference Device: | Cardicare Company, Ltd.; K082542<br>Shanghai Caremate Medical Device Co. Ltd;<br>K211084 |
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### Device Description:
### Aneroid Sphygmomanometer
The Aneroid Sphygmomanometer is a non-invasive blood pressure measurement system for monitoring blood pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff and an aneroid sphygmomanometer to measure pressure. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of an aneroid qauge, cuff, bladder, and inflation bulb. There are four models, including AS-ND-001, AS-ND-001LG, AS-ND-001CH, and AS-D-001. The differences between models are in the size, color, and material of the cuff.
### Single Patient Use Aneroid Sphygmomanometer
The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. The proposed device is OTC, non-invasive, non-automated, and non-sterile.
The proposed device consists of a manometer, cuff, and inflation bulb. There are four models: AS-SPU-W, AS-SPU-Y, AS-SPU-LG, and AS-SPU-CH. The differences between models are in the size and color of the cuff.
Both types of aneroid sphygmomanometers use the same measurement method of the Korotkoff sounds method; they are all reusable same measurement range and accuracy. The single-patient use type is for single-patient multiple uses only to avoid cross infection. Both types of aneroid sphygmomanometer can be sold with/without optioned stethoscopes which have been listed with the FDA.
The proposed device is Over-The-Counter use, non-sterile, reusable device.
### Principles of Operation/Measurement Method:
Auscultatory Korotkoff sounds method
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| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device | Aneroid Sphygmomanometer<br>Single Patient Use Aneroid<br>Sphygmomanometer | Aneroid Sphygmomanometer | Aneroid Sphygmomanometer | - | |
| Submitter | Cardicare Company, Ltd. | Cardicare Company, Ltd. | Shanghai Caremate Medical Device<br>Co. Ltd | - | |
| 510(K) Number | Pending | K082542 | K211084 | - | |
| Classification | 2 | 2 | 2 | Same | |
| Regulation Number | 870.1120 | 870.1120 | 870.1120 | Same | |
| Product Code | DXQ | DXQ | DXQ | Same | |
| Classification Name | Blood pressure cuff | Blood pressure cuff | Blood pressure cuff | Same | |
| | K222652 | | | | |
| Characteristics | | Discussion | | | |
| | Indication for Use | The Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. | The Aneroid Sphygmomanometer with Stethoscope, Model HBPK-A, is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (noninvasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users at hospitals or at home to monitor both systolic and diastolic pressure. This device is sold with an adult D size cuff and suitable for use on adults. | The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults and adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. | Note 1 |
| | | The Single Patient Use Aneroid Sphygmomanometer is intended to be used in a healthcare facility by medical professionals or in the home to measure systolic and diastolic pressure on children and adults. The device is intended to be manually attached to a patient and manually inflated, along with a manual method for detecting Korotkoff sounds. | Reusable | Same | |
| Usage | Measurement Method | Korotkoff sounds method | Reusable | Same | |
| K222652 | | | | | |
| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
| Patient Population | Children, young adults and adults | Adult | New borns, infants, children, young adults and adults | Note 2 | |
| OTC or Rx | OTC | OTC | OTC | Same | |
| Material | Manometer: Aluminum or Zinc+ABS<br>Cuff: Nylon or cotton or PVC<br>Bladder: PVC<br>Tubing: PVC<br>Hook: Nylon<br>Loop: Nylon | Manometer: Zinc<br>Cuff: Cotton or nylon<br>Latex bladder: Latex or PVC<br>The head of the stethoscope: Aluminum alloy<br>The membrane of the stethoscope: PVC<br>The tube of the stethoscope: PVC | Manometer: aluminum or ABS<br>Tubing, inflation bulb, and cuff bladder: Neoprene or Silicon rubber or Nature latex or PVC<br>Cuff: Nylon cloth for the outside layer | Note 3 | |
| Tube Quantity | 2 | 2 | 2 | Same | |
| Cuff Circumference (Range in mm) | Conforms to AHA bladder sizes recommendations:<br>Fits arm circumferences 120 mm-508 mm. The standard cuff should be available to measure a child, adult, and adult with large arms. | Adult (with D ring): 24-32cm | Fits arm circumferences 100mm-620mm, the standard cuff should be available for use in measuring a Newborn, infant, or child's leg blood pressure and for a child, young adult, and adult with larger arms | Note 4 | |
| K222652 | | | | | |
| Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion | |
| Cuff Sizes | For Aneroid Sphygmomanometer cuff<br>Adult: 53 x 14.5cm<br>Large adult: 62 x 17.5cm<br>Child: 34 x 11cm<br>Adult (with D ring): 50 x 14cm<br><br>For Single Patients, Use the Aneroid<br>Sphygmomanometer cuff<br>Adult: 53 x 15cm<br>Large Adult: 63 x 17.5cm<br>Child: 31 x 8.5 cm | Adult (with D ring): 50 x 14cm | 31.49" X 8.66" (800mm*220mm)<br>24.41" × 6.89" (620mm*175mm)<br>20.47" × 5.51" (520mm*140mm)<br>13.4" x 4.33" (340mm*110mm)<br>9.84"×3.15" (250mm*80mm)<br>8.27" × 2.36" (210mm*60mm ) | Note 5 | |
| Cuff Bladder<br>Size | For Aneroid Sphygmomanometer<br>Adult:22 x 12 cm<br>Large adult: 31 x 13.5 cm<br>Child: 17.5 x 8.5 cm<br>Adult (with D ring): 22 x 12cm<br><br>For Single Patient Use Aneroid<br>Sphygmomanometer<br>The cuff bladder is integrated with the<br>cuff. The device has no separate bladder. | Adult (with D ring): 22 x 12cm | 13.39" X 6.69" (340mm*170mm)<br>12.2"×5.51" (310mm*140mm)<br>8.66"×4.72" (220mm*120mm)<br>6.69"×3.15" (170mm*80mm)<br>4.33" x 2.36" (110mm*60mm)<br>3.15" X 1.57" (80mm*40mm) | Note 6 | |
| Pressure<br>Limits | 0-300mmHg | 0-300mmHg | 0-300mmHg | Same | |
| K222652 | Characteristics | Subject Device | Primary Predicate Device | Reference Device | Discussion |
| Accuracy | Pressure +/-3mmHg of reading | Pressure +/-3mmHg of reading | Pressure +/-3mmHg of reading | Same | |
| Anatomical Sites | Upper Arm | Upper Arm | Upper Arm (leg for child) | Same | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same | |
| Inflation | Manual by inflation bulb | Manual by inflation bulb | Manual by inflation bulb | Same | |
| Deflation | Manual deflation via valve | Manual deflation via valve | Manual deflation via valve | Same | |
| Display | Aneroid Manometer | Aneroid Manometer | Aneroid Manometer | Same | |
| Performance | Conforms to ISO 81060-1 | Conforms to ISO 81060-1<br>(previous ANSI/AAMI SP10) | Conforms to ISO 81060-1 | Same | |
| Biocompatibility | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Conforms to ISO10993-1 | Same | |
# Comparison of Technological Characteristics with the Predicate Devic
# K22652
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### Discussion:
### Note 1: Indications for use
The subject devices, including the conventional type and single patient use type, are both reusable. The measurement method and intended use for both types are the same as our previously cleared predicate device and reference device, except the single-patients use type is for single-patient use only. Both conform to the same applicable performance standards.
The indication for use statement for the subject devices has been standardized to meet the requirements of most recently cleared devices under product code-DXQ and similar reference devices. The difference doesn't raise new questions of safety or effectiveness compared to the predicate.
### Note 2: Patient Population
The tarqet population of the subject devices is larger than the predicate device but still covered by the reference devices, the same as most recently cleared aneroid sphygmomanometer devices.
They conform to the same performance standards (ISO81060-1). Therefore, the difference in the target population does not raise new questions on the safety and effectiveness of the subject device.
### Note 3: Material
Although minor material differences exist among subject devices, predicate devices, and reference devices, they all conform to the same ISO10993-1 biocompatibility standards.
### Note 4: Cuff circumference
The arm circumference for the proposed cuff is 120 mm-508 mm, and the arm circumference for the predicate cuff is 240-320 mm, the arm circumference for the reference cuff is 100 mm - 620 mm. The range of arm circumferences for the subject device is covered by the reference device, and they conform to the same performance standards; therefore, the difference in cuff circumference does not raise new questions on the safety and effectiveness of the subject device.
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# Note 5: Cuff sizes
The subject device's cuff sizes differ from the predicate and reference devices. However, the cuff size of the subject device is similar to the predicate device and the reference device. The Velcro on the cuff is designed to fit various arm circumferences. This difference doesn't raise new problems reqarding the safety and effectiveness of the subject device. Therefore, this difference in cuff size does not introduce new questions on the safety and efficacy of the subject device.
### Note 6: Cuff bladder size
The cuff bladder size is similar to the predicate device and reference device for Aneroid Sphygmomanometer. It could fit various requirements of users. For Sinqle Patient Use of an Aneroid Sphygmomanometer, the cuff bladder is integrated with the cuff and has no separate bladder.
However, the subject devices conform to ISO 81060-1. Therefore, this difference in cuff bladder size does not raise new questions on the safety and effectiveness of the subject device.
# Performance Testing
Performance testing was provided to support the substantial equivalence determination and to validate & verify that the subject devices met all requirements of related applicable standards. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
### Non-Clinical Testing
Non-clinical testing was performed to verify substantial equivalence to the predicate device.
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# K222652
# Performance:
Non-invasive sphygmomanometers performance testing per ISO 81060-1:2007; ISO 81060-1 First edition 2007-12-01 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
# Biocompatibility:
The biocompatibility evaluation for the patient contact reusable cuff was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993: Biological Evaluation of Medical Devices Part 1: Evaluation and testing with a risk management process, September 4, 2020, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The testing items included: ISO 10993-5: 2009 In Vitro Cytotoxicity ISO 10993-10: 2010 Skin Irritation
ISO 10993-10: 2010 Skin Sensitization
# Clinical Performance Data
No clinical data were required to demonstrate substantial equivalence.
# Conclusions:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Aneroid Sphygmomanometer and Single Patient Use Aneroid Sphygmomanometer is substantially equivalent to the Cardicare Company, Ltd., Aneroid Sphygmomanometer With Stethoscope Model HBPK-A cleared under K082542 and the Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope, manufactured by Shanghai Caremate Medical Device Co. Ltd, cleared under K211084 concerning the indications for use, target populations, treatment method, and technological characteristics.
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