(347 days)
The FlexiPort™ Blood Pressure Cuff is used in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The FlexiPort™ Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.
FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers and inflation devices. This allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another to be used universally within a facility on multiple devices. The port connector can also rotate 360 degrees to reduce tube kinking.
The Welch Allyn FlexiPort™ Blood Pressure Cuff is designed to measure blood pressure in conjunction with noninvasive blood pressure measurement systems. The device is intended for pediatric through adult sizes and is not for neonatal applications.
1. Table of Acceptance Criteria & Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Conforms to ISO 10993-1 |
| Compatibility with other devices | Tested and demonstrated compatible with other devices |
| Reprocessing | Tested and demonstrated effective reprocessing |
| Packaging | Tested and demonstrated effective packaging |
| Sterilizability | Capable of being sterilized using ETO |
| Environmental | Not explicitly detailed, but implied to meet standards through overall testing |
| Mechanical Strength | Not explicitly detailed, but implied to meet standards through overall testing |
| Durability | Tested for repeated inflations; implied to meet durability standards |
| Accuracy | Conforms to AAMI SP10, 2002 requirements for Non-Automated Sphyg. |
| AAMI/AHA bladder sizes | Conforms to AAMI/AHA bladder sizes |
2. Sample size used for the test set and the data provenance:
The provided summary does not explicitly state a specific sample size for the test sets.
The data provenance is not explicitly mentioned but would be considered retrospective as the testing was done to demonstrate conformance to existing standards and predicate device characteristics, not as an ongoing clinical trial. The testing was conducted by Welch Allyn, Inc. in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document. The study relies on established industry standards (AAMI SP10, ISO 10993-1, AAMI/AHA bladder sizes) and bench/laboratory testing, rather than expert interpretation of results from a specific test set requiring ground truth establishment by human experts.
4. Adjudication method for the test set:
An adjudication method is not applicable as the evaluation relies on objective measurements against predetermined standards and predicate device comparisons, not subjective interpretations requiring expert consensus.
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:
This is not applicable. The device is a blood pressure cuff and does not involve AI or human "readers" in the context of image interpretation or diagnostic assistance. It is a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on:
- Established industry standards: AAMI SP10, ISO 10993-1, and AAMI/AHA bladder sizes.
- Bench and laboratory testing: Physical measurements and evaluations to demonstrate conformance to these standards and equivalence to predicate devices.
8. The sample size for the training set:
This is not applicable as there is no mention of a "training set" in the context of this physical medical device.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
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WelchAllyn
| 5. | Premarket Notification [510(k)] Summary | K070060Pg 1 of 2 | |
|---|---|---|---|
| Date: | January 3, 2007 | ||
| Submitted By: | Welch Allyn, Inc. | ||
| 4341 State Street Road, P.O. Box 220 | |||
| Skaneateles Falls, NY 13153-0220 | DEC 1 8 2007 | ||
| Phone: | (315) 685-4571 | ||
| Fax: | (315) 685- 2532 | ||
| Contact: | John Sawyer | ||
| Vice President, Quality Assurance and Regulatory Affairs | |||
| Common Name: | Blood Pressure Cuff | ||
| Trade Name: | Welch Allyn FlexiPort™ Disposable Blood Pressure Cuff (One-Piece)Welch Allyn FlexiPort™ Reusable Blood Pressure Cuff (One-Piece) | ||
| Classification Name: | Cuff, Blood-Pressure | ||
| Classification: | Class II per 21 CFR 870.1120 | ||
| Predicate Devices: | Critikon Soft Blood Pressure Cuff (K974080) | ||
| Sensa-Cuff, Models Infant, Child, Adult (K022482) | |||
| Description: | FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, astandardized connector for quick exchange of tubing and fittings thatinterface with manual or electronic sphygmomanometers and inflationdevices. This allows the interface tubing (either one- or two-tube) toremain with the blood pressure measurement device, while the cuff can beeasily removed and moved from one location to another to be useduniversally within a facility on multiple devices. The port connector canalso rotate 360 degrees to reduce tube kinking. | ||
| Intended Use: | The FlexiPort™ Blood Pressure Cuff is used in conjunction withnoninvasive blood pressure measurement systems. The cuff is nonsterileand is available in pediatric through adult sizes. The device is not intendedfor neonatal applications. The FlexiPort™ Blood Pressure Cuffs are notdesigned, sold, or intended for use, except as indicated. | ||
| Performance: | Bench and laboratory testing was conducted to demonstrateperformance of the Welch Allyn FlexiPort™ Blood Pressure Cuff.• Biocompatibility• Compatibility with other devices• Reprocessing• Packaging |
Section 5 - Page 1 of 1 :
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WelchAllyn
Traditional 510(k) Premarket Notification Welch Allyn FlexiPort™ Blood Pressure Cuffs
070060
Pa 2 &Z
- Sterilizability .
- . Environmental
- . Mechanical Strength
- . Durability
- Accuracy .
Subject Device and Predicate Device Comparison:
| Subject Area | Welch Allyn FlexiPort™ | GE Sensa-Cuff | Critikon Soft BloodPressure Cuff |
|---|---|---|---|
| Indications ForUse | Indirect measurement of bloodpressure | Indirect measurement of bloodpressure | Indirect measurement of bloodpressure |
| Sizes - armcircumference(Ranges in cm) | Newborn (7-10)Infant (9-13)Small Child (12-16)Child (15-21)Small Adult (20-26)Adult (25-34)Large Adult (32-43)Thigh (40-55) | Infant (8-13)Child (12-19)Small Adult (17-25)Adult (23-33)Large Adult (31-40)Thigh (38-50) | Neonatal 1 (3-6)Neonatal 2 (4-8)Neonatal 3 (6-11)Neonatal 4 (7-13)Neonatal 5 (8-15)Infant (8-13)Child (12-19)Small Adult (17-25)Adult (23-33)Large Adult (31-40)Thigh (38-50) |
| TubeConfiguration | 1 and 2 tube, interchangeable | 1 and 2 tube, built intospecific cuff model number | 1 and 2 tube, built intospecific cuff model number |
| Safety & Efficacy | AAMI SP10, 2002requirements for Non-Automated Sphyg.(SP10 is revision-update ofSP9) | AAMI SP9 requirements forNon-Automated Sphyg. | Bench and laboratory tested todemonstrate conformance forbiocompatibility, validation ofreprocessing, and repeatedinflations. |
| ISO 10993-1 biocompatibility | ISO 10993-1, biocompatibility | ||
| AAMI/AHA bladder sizes | AAMI/AHA bladder sizes | AAMI/AHA bladder sizes | |
| Sterility | Not supplied sterile. Capableof being sterilized using ETO. | Not supplied sterile. | Not supplied sterile. |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 | Demonstrated performance forbiocompatibility |
In accordance with the Federal Food, Drug and Cosmetic Act and 21 Conclusion: CFR Part 807, and based on the information provided in this premarket notification, Welch Allyn concludes that this device, the
Welch Allyn FlexiPort™ Blood Pressure Cuff, is safe, effective and substantially equivalent to both the reusable GE Sensa-Cuff (K022482) and the disposable Critikon Soft Blood Pressure Cuff (K974080)
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three curved lines extending from its head.
DEC 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Welch Allyn, Inc. c/o Mr. John Sawyer VP Quality Assurance and Regulatory Affairs 4341 State Street Road, Box 220 Skaneateles Falls, NY 13151-0220
Re: K070060
Trade/Device Name: FlexiPort Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: November 9, 2007 Received: November 13, 2007
Dear Mr. Sawyer:
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 mav publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. John Sawyer
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); good manufacturing practice requirements as set forth in the quality systems 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,
Bfremmerfor
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
Konooco 510(k) Number (if known):
Welch Allyn FlexiPort™ Disposable Blood Pressure Cuff (One-Piece) Device Name: Welch Allyn FlexiPort™ Reusable Blood Pressure Cuff (One-Piece)
Indications for Use:
The FlexiPort™ Blood Pressure Cuff is used in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The FlexiPort™ Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.
Prescription Use __ Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.Benson
(Division Sign-Off)
(Division Sign-Off) Division of Cardioyascular Devices 510(k) Number
Page 1 of 1
§ 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).