(196 days)
The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated: Prescription Use, Part 21 CFR 801 Subpart D
Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and
The provided document describes the Legacy Medical Blood Pressure Cuff, which is intended for use with non-invasive blood pressure measuring devices. The document highlights the regulatory submission (510(k) summary) and the performance testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI SP10 (2002+A1:2003+A2:2006+(R)2008) for manual, electronic, or automated sphygmomanometers | Tested according to the standard. Non-clinical tests showed substantial equivalence in functional and operational performance characteristics including compression, pressure control, and leakage when connected to inflation and measurement equipment. |
| ISO 10993-5 (1999) Biological evaluation of medical devices, Part 5: Tests for In Vitro cytotoxicity | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
| ISO 10993-12 (Date not specified) Biological Evaluation of Medical Devices, Part 12: Sample Preparation and Reference Materials | Tested according to the standard. (No specific performance data beyond "tested according to" provided in this document segment for this standard). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "comparative bench testing" as the method used to assess and prove similarity of function between the Legacy Medical Blood Pressure Cuff and predicate devices.
- Sample Size: The document does not specify the sample size used for the test set. It only mentions "non-clinical tests."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's "bench testing," it's likely conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document describes "non-clinical tests" and "comparative bench testing" for functional and operational performance. This type of testing typically relies on standardized measurement equipment and protocols rather than human expert opinion to establish ground truth for performance parameters like compression, pressure control, and leakage.
Therefore, this section is not applicable as expert consensus is not the method for establishing ground truth for these types of mechanical and functional performance tests.
4. Adjudication Method for the Test Set:
As mentioned above, the testing involved "comparative bench testing" against predicate devices using objective measurements. This typically does not involve an adjudication method in the context of human interpretation or review. Therefore, this section is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Non-clinical tests - comparative bench testing was utilized to assess and prove similarity of function." This type of study focuses on mechanical and functional performance, not human reader interpretation of images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This section is not applicable. The device is a physical blood pressure cuff, not an algorithm or AI system. The testing described is for the physical and functional aspects of the cuff.
7. The Type of Ground Truth Used:
The ground truth for the "comparative bench testing" appears to be based on objective measurements performed in accordance with established engineering and medical device standards (ANSI/AAMI SP10, ISO 10993). The performance of the Legacy Medical Blood Pressure Cuff was compared against these standards and against the performance of predicate devices.
8. The Sample Size for the Training Set:
This section is not applicable. The device is a physical medical device (blood pressure cuff), not a machine learning or AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for Legacy Medical, Inc. The logo features a stylized figure within a circular design, with the text "Legacy Medical, Inc." to the right of the figure. The figure appears to be reaching upwards, and the overall design is simple and professional.
Legacy Medical, Inc. 9039 Horizon Drive, Shakopee, MN 55379 Tel: 952-322-7240 Fax: 866-498-5854 Web www.legacy-medical.com
IV. 510(k) Summary
| Submitter: | Legacy Medical, Inc. 9039 Horizon Drive Shakopee, MN 55379 |
|---|---|
| ------------ | ------------------------------------------------------------ |
OCT 17 2013
Date: March 27, 2013
Contact Person: Debra Robertson, President Tel: 952-322-7240
Name of Device:
| Classification Name: | Cuff, Blood Pressure CFR 870.1120 |
|---|---|
| Common Name: | Non-invasive blood Pressure Cuff |
| Review Panel: | Cardiovascular |
| Classification: | Class II |
| Product Code: | DXQ |
| Proprietary Name: | Legacy Medical Blood Pressure Cuff |
Predicate Devices:
| Device | Manufacturer | 510(k) |
|---|---|---|
| Critikon Soft-Cuf Blood Pressure Cuff | GE Healthcare | K974080 |
| Disposa-Cuff Blood Pressure Cuff | Crest MedicalEquipment | K790810 |
| Surgi-Cuff | Ethox Corporation | K883977 |
| Cuff-Able Blood Pressure Cuff | Vital Signs, Inc | K911213 |
| Statcorp Disposable Blood PressureCuff | Statcorp, Inc | K940214 |
| Technicuff | Technicuff Corp. | K942259 |
Device Description:
Per CFR 870.1120, a blood pressure cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure.
The Legacy Medical Blood Pressure Cuff comprises a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and
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Image /page/1/Picture/1 description: The image shows a logo for Legacy Medical, Inc. The logo features a stylized image of a person with their arms raised, surrounded by a circle and two leaves. The text "Legacy Medical, Inc." is written in a simple, sans-serif font to the right of the image.
Legacy Medical, Inc. 9039 Horizon Drive, Shakopee, MN 55379 Tel: 952-322-7240 Fax: 866-498-5854 Web www.legacy-medical.com
III. Statement of Indications for Use
Indications for use: 510(k) number: Pending Device name: Legacy Medical Blood Pressure Cuff Indications for use:
The Legacy Medical Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated:
Prescription Use, Part 21 CFR 801 Subpart D
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Image /page/2/Picture/1 description: The image shows the logo for Legacy Medical, Inc. The logo features a stylized human figure with arms raised inside a circular shape. The text "Legacy Medical, Inc." is written in a simple, sans-serif font to the right of the figure.
Legacy Medical, Inc. 9039 Horizon Drive, Shakopee, MN 55379 Tel: 952-322-7240 Fax: 866-498-5854 Web www.legacy-medical.com
Performance Summary:
The Legacy Medical blood pressure cuff has been tested according to the following standards:
-
ANSI/AAMI SP10. Manual. . electronic or automated
sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008 -
ISO 10993-5, Biological evaluation of medical devices, Part 5: .
Tests for In Vitro cytotoxicity, 1999 -
ISO 10993-12, Biological Evaluation of Medical Devices, Part 12: .
Sample Preparation and Reference Materials
Performance Data:
Non-clinical tests - comparative bench testing was utilized to assess and prove similarity of function between the Legacy Medical Blood Pressure Cuff and the predicate devices. Tests showed that the functional and operational performance characteristics including compression, pressure control, leakage and both safety and operational parameters used when connected to inflation and measurement equipment were substantially equivalent.
Test conclusion - Non-clinical test results of the Legacy Medical Blood Pressure Cuff indicated substantial equivalence in the measured characteristics to the predicate devices.
Statement of Substantial Equivalence:
The Legacy Medical Blood Pressure Cuff is substantially equivalent in technology, function, operating parameters, and intended use to the blood pressure cuffs that are currently commercially available and in distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
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October 17, 2013
Legacy Medical, Inc. C/O Deb Robertson 9039 Horizon Dr Shakopee, MN 55379 US
K130942 Re:
Trade/Device Name: Legacy Medical Eco-Choice Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Non-Invasive Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: August 30, 2013 Received: September 16, 2013
Dear Deb Robertson:
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 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 (reporting of medical device-related adverse labeling (21 CFR 803); 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.
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Page 2 - Deb Robertson
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K130942
Image /page/5/Picture/1 description: The image shows the logo for Legacy Medical, Inc. The logo features a stick figure with its arms raised inside of a circle. Above the stick figure are two dome-shaped objects that are connected to the circle. To the right of the circle is the text "Legacy Medical, Inc."
Legacy Medical, Inc. 9039 Horizon Drive, Shakopee, MN 55379 Tel: 952-322-7240 Fax: 866-498-5854 Web www.legacy-medical.com
Indications for Use
510(k) Number (if known): K130942 Device Name: Eco Choice Blood Pressure cuff Indications For Use:
The Legacy Medical Eco Choice Blood Pressure cuff is an accessory used in conjunction with non-invasive blood pressure measuring devices to measure systolic and diastolic blood pressures and heart rate. It is non-sterile and may be used with neonatal, pediatric and adult patients. The cuff is not designed, sold or intended for use except as indicated.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Page 1 of
Digitally signed by
Owen P. Faris -S
Date: 2013.10.17
15:34:29 -04'00'
§ 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).