(29 days)
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
Here's a breakdown of the acceptance criteria and study information for the Statcorp Medical UltraCheck® Spacelabs ABP Cuffs, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document specifically refers to clinical accuracy testing performed "per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)." While the table below summarizes the core requirements of this standard, the document does not explicitly state the numerical acceptance criteria met by the device for each specific requirement. Instead, it generally concludes that the device performed per the methodology and requirements.
| Acceptance Criteria (Based on AAMI ANSI ISO 81060-2 (2013) - General Requirements) | Reported Device Performance |
|---|---|
| Criterion 1: Mean difference between the test device and reference measurement for systolic blood pressure (SBP) ≤ ±5 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 2: Standard deviation of the differences for SBP ≤ 8 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 3: Mean difference between the test device and reference measurement for diastolic blood pressure (DBP) ≤ ±5 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 4: Standard deviation of the differences for DBP ≤ 8 mmHg. | Performed per methodology and requirements of AAMI ANSI ISO 81060-2 (2013). |
| Criterion 5 (Additional Mechanical Tests): Pressure cycle testing to 10,000 cycles for life validation. | Met (validated life). |
| Criterion 6 (Additional Mechanical Tests): Application testing to 1,000 cycles for life validation. | Met (validated life). |
| Criterion 7 (Additional Mechanical Tests): Mechanical stress testing for ring durability. | Met (validated ring durability). |
| Criterion 8 (Additional Mechanical Tests): Cleaning validation tests for cleaning recommendations. | Met (validated cleaning recommendations). |
| Criterion 9 (Additional Mechanical Tests): Label integrity testing for chemical resistance and legibility. | Met (validated label chemical resistance and legibility). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample size (number of subjects/measurements) used for the clinical accuracy testing. AAMI ANSI ISO 81060-2 (2013) typically recommends a minimum of 85 subjects for validation studies.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide this information. For blood pressure cuff validation, ground truth is typically established by trained technicians using a reference device (e.g., mercurial sphygmomanometer with a stethoscope) following a strict protocol.
4. Adjudication Method for the Test Set:
The document does not provide this information. For blood pressure cuff validation, adjudication (e.g., by two independent observers measuring simultaneously) is often part of the AAMI standard's methodology.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No, an MRMC comparative effectiveness study was not performed.
- Effect Size of Human Readers with/without AI: Not applicable, as this is a medical device (blood pressure cuff) and not an AI-assisted diagnostic tool for image or data interpretation.
6. Standalone (Algorithm Only) Performance:
- Was it done?: Yes, in essence, the clinical accuracy testing performed per AAMI ANSI ISO 81060-2 (2013) is a standalone performance evaluation of the device in its intended use. The device (cuff) is being tested for its ability to accurately measure blood pressure.
7. Type of Ground Truth Used:
For the clinical accuracy testing, the ground truth would be reference blood pressure measurements obtained simultaneously using a validated and calibrated reference device (e.g., a mercurial sphygmomanometer with auscultation by trained observers), as per the AAMI ANSI ISO 81060-2 standard.
8. Sample Size for the Training Set:
Not applicable. This device is a blood pressure cuff, which does not employ machine learning or AI algorithms requiring a "training set" in the conventional sense. Its function is based on mechanical properties and calibrated pressure readings.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2015
Statcorp Medical Wayne Emmert Director of Operations 14476 Duval Place West Suite 303 Jacksonville, Florida 32218
Re: K152801
Trade/Device Name: Ultracheck Spacelabs ABP Cuff-child, Ultracheck Spacelabs ABP Cuff-small Adult, Ultracheck Spacelabs ABP Cuff-adult, Ultracheck Spacelabs ABP Cuff-large Adult
Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: September 25, 2015 Received: September 28, 2015
Dear Wayne Emmert:
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. 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.
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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152801
Device Name
Statcorp Medical UltraCheck Spacelabs ABP Cuffs
Indications for Use (Describe)
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are intended for use by or under the supervision of qualified medical personnel.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| x Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K152801
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UltraCheck® Spacelabs ABP Blood Pressure Cuffs 510(k) Summary of Safety and Effectiveness
1. Applicant Information
A. Applicant Information: Statcorp Medical 14476 Duval Place West, Suite 303 Jacksonville, FL 32218 1-904-786-5113
| B. Official Contact: | Wayne EmmertDirector of Operations |
|---|---|
| ---------------------- | ---------------------------------------- |
- C. Date of Summary: 9/25/15
II. Device Information
- A. Proprietary Name : UltraCheck® Spacelabs ABP Cuffs
- B. Common Names: Blood Pressure Cuff
- C. Classification Device Name: Blood Pressure Cuff
- D. Classification Regulatory Description: Blood Pressure Cuff
- E. Product Code: DXQ
- F. Regulatory Class: ==
- G. Panel: Cardiovascular
III. Predicate Device
The predicate devices for these cuffs are the Ultracuff Blood Pressure Cuffs (for Spacelabs ABP), 510(k) # K954282.
Statcorp Special 510(k) Section 8
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IV. General Description
The Statcorp UltraCheck® Spacelabs ABP cuffs in this 510(k), are applied to a patient limb and connected pneumatically to an oscillometric blood pressure monitor to enable noninvasive blood pressure measurements. The cuff is made of flexible polymeric material, a section of which forms an integrated inflatable bladder. The cuffs in this 510(k) are secured by looping the cuff through an attached oblong ring back onto itself to enable easier selfapplication. These cuffs are connected pneumatically through a one piece tube to the Spacelabs ABP Monitor.
V. Indications
The Statcorp UltraCheck® Spacelabs ABP Cuffs are used with identified devices intended for the non-invasive measurement of pediatric and adult human blood pressure.
UltraCheck® Blood Pressure Cuffs are intended for use by or under the supervision of qualified medical personnel.
VI. Comparison to Predicate
The UltraCheck® Spacelabs ABP cuffs in this 510(k) are similar to the Statcorp Ultracuff described in K954282 in that use the same cuff materials, bladder sizes and methods of construction. It differs from the fact that these cuffs are designed to be applied by passing the extended portion through a ring and attaching the cuff back onto itself. The predicate device is merely wrapped around the arm in the same direction. There is also an added fringe on the weld side of the cuff which eases the transition from the stiffer portion of the weld to the edge of the cuff which is added to provide for patient comfort.
VII. Test Summary
Mechanical tests included
- . Pressure cycle testing to 10,000 cycles and application testing to 1,000 cycles to validate life.
- Mechanical stress testing to validate ring durability .
- Cleaning validation tests to validate cleaning recommendations .
- Label integrity testing to validate label chemical resistance and legibility .
Clinical Accuracy testing performed per the methodology and requirements of AAMI ANSI ISO 81060-2 (2013)
VIII. Conclusions
Based upon the above test results the Statcorp Medical UltraCheck® Spacelabs ABP Cuffs are substantially equivalent to the predicate devices cited and safe and effective for their stated intended use.
§ 870.1120 Blood pressure cuff.
(a)
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.(b)
Classification. Class II (performance standards).