(16 days)
The DuraShock™ Blood Pressure System is intended for the non-invasive blood pressure measurement of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated. The Welch Allyn® DuraShock™ Blood Pressure System is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn® DuraShock™ child is the smallest cuff approved for use with children and infants whose arm circumference fit within the range markings on the cuff.
The Welch Allyn® DuraShock™ Blood Pressure System is a non-invasive blood pressure (BP) measurement device. The DuraShock™ Blood Pressure System is designed to non-invasively measure systolic and diastolic blood pressure for adult and pediatric patients. The Welch Allyn® DuraShock™ Blood Pressure System consists of five components, DuraShock™ Gauge, Integrated One Piece Cuff, Bulb, Valve, and Tubing. The DuraShock™ Blood Pressure System comes in two models. Model ds44 is a lower cost unit with a 5 year warranty, while model ds45 is a higher cost unit that carries a 10 year warranty. Each model will be available in four cuff sizes, Large Adult, Adult, Small Adult, and Child which conform to AAMI SP-9, and AHA. The DuraShock™ Gauge is revolutionary, in that in place of a gear driven movement as found in traditional aneroids, the NCA spring driven movement will be utilized, providing the user with a more durable aneroid. The NCA spring driven movement as opposed to using gears, diaphragm travel is converted to pointer rotation by using a spring wrapped around a pin. The DuraShock™ system also features a Integrated one piece cuff with integral bladder that contains a port where the DuraShock™ Gauge can be directly inserted into the bladder of the cuff. This point of attachment of gauge to cuff, will make it more convenient for use, as well as making it easier for the clinician to read. By attaching directly to the bladder, this will allow the clinician to read the gauge without holding it, thus freeing up their hands to hold the stethoscope head, and bulb and valve to inflate the cuff. The DuraShock™ model ds45 configurations, will utilize a black neoprene bulb, metal valve, and black TPR tubing that is currently being used on the Welch Allyn Tycos® Econo Blood Pressure System. On DuraShock™ model ds44 configurations, a plastic valve, gray PVC bulb and gray TPR tubing will be used.
Here's a breakdown of the acceptance criteria and study information for the Welch Allyn® DuraShock™ Blood Pressure System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Welch Allyn® DuraShock™ Blood Pressure System) | Reported Device Performance (Welch Allyn® DuraShock™ Blood Pressure System) |
|---|---|---|
| Blood Pressure | ||
| BP Determination Method | Non-invasive | Non-invasive (for both ds45 and ds44 models) |
| Initial Cuff Inflation | Operator dependent capable of inflation to 300 mmHg. | Operator dependent capable of inflation to 300 mmHg. (for both ds45 and ds44 models) |
| Measurement Range | ||
| Systolic | 20-300 mmHg | 20-300 mmHg (for both ds45 and ds44 models) |
| Diastolic | 20-300 mmHg | 20-300 mmHg (for both ds45 and ds44 models) |
| Measurement Accuracy | AAMI SP9-1994 (for Blood Pressure) | AAMI SP9-1994 (for Blood Pressure) (for both ds45 and ds44 models) |
| Cuff Pressure Accuracy | +/- 3 mmHg | +/- 3 mmHg (for both ds45 and ds44 models) |
| Measurement time | 30-60 sec. Typical | 30-60 sec. Typical (for both ds45 and ds44 models) |
| Overall System | ||
| Patient Population | Pediatric/Adult | Pediatric/Adult (for both ds45 and ds44 models) |
| Display Type | Dial | Dial (for both ds45 and ds44 models) |
| Operating Temperature | 0 to 46 °C | 0 to 46 °C (for both ds45 and ds44 models) |
| Humidity Range | 0 to 85% RH non-condensing | 0 to 85% RH non-condensing (for both ds45 and ds44 models) |
| Storage Temperature | -34 to 70 °C | -34 to 70 °C (for both ds45 and ds44 models) |
Study Details:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a full clinical effectiveness study with exhaustive information about ground truth establishment, reader studies, etc. It primarily relies on meeting established industry standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to compliance with AAMI SP9-1994 for blood pressure measurement accuracy. This standard typically defines the requirements for clinical validation, including the number of subjects to be recruited (usually a minimum of 85 subjects with specific age and gender distribution). However, the specific number of subjects used in Welch Allyn's testing is not mentioned in this summary.
- Data Provenance: Not explicitly stated. The study for AAMI SP9-1994 compliance would involve prospective collection of blood pressure measurements from human subjects. The geographical origin of these subjects is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. For AAMI SP9-1994 validation, ground truth is typically established by trained observers (often two or three) using a mercury sphygmomanometer, following a specific protocol to minimize bias.
- Qualifications of Experts: Not explicitly stated. However, in studies adhering to AAMI SP9-1994, the observers are highly trained and experienced in taking auscultatory blood pressure measurements.
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. For AAMI SP9-1994 clinical validation, if multiple observers are used, their readings are typically used to establish a consensus or averaged reference value. The standard outlines methodologies for comparing the test device's readings against these reference measurements. A common approach involves averaging multiple mercury sphygmomanometer readings.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure measurement device (sphygmomanometer), not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, the concept of improving human readers with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance criteria listed (e.g., +/- 3 mmHg cuff pressure accuracy, AAMI SP9-1994 blood pressure accuracy) describe the standalone performance of the blood pressure system. While a human operates the device (inflates the cuff, reads the dial), the accuracy metrics refer to the device's ability to measure blood pressure correctly against a reference standard, independent of human interpretive errors typically associated with AI diagnostic systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Expert Consensus / Reference Method: The ground truth for blood pressure measurement accuracy would be established by simultaneous or sequential auscultatory blood pressure measurements taken by highly trained observers using a calibrated reference method, typically a mercury sphygmomanometer. This aligns with the requirements of AAMI SP9-1994.
8. The sample size for the training set:
- Not applicable / Not stated. This device is a mechanical sphygmomanometer, not an AI or machine learning system that requires a "training set" in the conventional sense. Its design and calibration are based on engineering principles and adherence to established measurement standards, rather than data-driven learning.
9. How the ground truth for the training set was established:
- Not applicable. As mentioned above, there is no "training set" for this type of device. The accuracy is inherently designed and validated against physical measurement principles and physiological reference methods.
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Kd2455
AUG 1 7 2001
510(k) Summary II.
[As described in CFR 807.92]
| Submitted by: | Welch Allyn Inc.95 Old Shoals RoadArden, NC 28704 |
|---|---|
| Contact Person: | David A. Young IIQuality Assurance Engineer |
| Date Prepared: | 15 January 2001 |
| Proprietary Name: | Welch Allyn® DuraShock™ Blood Pressure System |
| Common Name: | Blood Pressure Sphygmomanometer |
| Classification Name: | Class II 870.1120 Blood Pressure Cuff |
| Predicate Device: | Welch Allyn, Tycos® Econo Blood PressureSphygmomanometerWelch Allyn, Inc.510(k) Document Control Number NA (predicate device isa pre-amendment device) |
Description of the Device:
The Welch Allyn® DuraShock™ Blood Pressure System is a non-invasive blood pressure (BP) measurement device. The DuraShock™ Blood Pressure System is designed to non-invasively measure systolic and diastolic blood pressure for adult and pediatric patients. The Welch Allyn® DuraShock™ Blood Pressure System consists of five components, DuraShock™ Gauge, Integrated One Piece Cuff, Bulb, Valve, and Tubing. The DuraShock™ Blood Pressure System comes in two models. Model ds44 is a lower cost unit with a 5 year warranty, while model ds45 is a higher cost unit that carries a 10 year warranty. Each model will be available in four cuff sizes, Large Adult, Adult, Small Adult, and Child which conform to AAMI SP-9, and AHA. The DuraShock™ Gauge is revolutionary, in that in place of a gear driven movement as found in traditional aneroids, the NCA spring driven movement will be utilized, providing the user with a more durable aneroid. The NCA spring driven movement as opposed to using gears, diaphragm travel is converted to pointer rotation by using a spring wrapped around a pin. The DuraShock™ system also features a Integrated one piece cuff with integral bladder that contains a port where the DuraShock™ Gauge can be directly inserted into the bladder of the cuff. This point of attachment of gauge
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to cuff, will make it more convenient for use, as well as making it easier for the clinician to read. By attaching directly to the bladder, this will allow the clinician to read the gauge without holding it, thus freeing up their hands to hold the stethoscope head, and bulb and valve to inflate the cuff. The DuraShock™ model ds45 configurations, will utilize a black neoprene bulb, metal valve, and black TPR tubing that is currently being used on the Welch Allyn Tycos® Econo Blood Pressure System. On DuraShock™ model ds44 configurations, a plastic valve, gray PVC bulb and gray TPR tubing will be used.
The Welch Allyn® DuraShock™ Blood Pressure System is intended for use in a wide variety of settings. This includes hospital departments, alternate care settings, such as physician offices, freestanding ambulatory care and surgery centers, health clinics and nursing homes, as well as home health care.
Indications/Contraindications For Use of the Device:
The Welch Allyn® DuraShock™ Blood Pressure System has the same intended use as the predicate device. The device is intended for the non-invasive blood pressure measurements of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated.
The Welch Allyn® DuraShock™ Blood Pressure System is not designed for use
with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn® DuraShock™ Child cuff is the smallest cuff approved for use with DuraShock™ aneroid on children and infants. For the DuraShock™ Blood Pressure System to accurately determine blood pressure, the circumference of the child or infant's arm must fit within the range markings on the cuff.
Technological Characteristics:
The Welch Allyn® DuraShock™ Blood Pressure System differs from the predicate device, in that it utilizes the NCA spring movement in place of the traditional gear driven movement. The DuraShock™ Blood Pressure System also utilizes a Integrated one piece cuff that has a port in which the DuraShock™ gauge can be inserted directly into the bladder of the cuff. The predicate device utilizes a hose port, and length of black TPR tubing to attach the gauge to the cuff. The same black neoprene manual bulb, valve, and black TPR tubing will be utilized on the DuraShock™ model ds45 that is currently used on the predicate device, while model ds44 will use a plastic valve, gray PVC bulb and gray TPR tubing will be used. The following table summarizes the similarities and differences between the Welch Allyn® DuraShock™ Blood Pressure System and the Welch Allyn Tycos® Econo Blood Pressure System.
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Table 1
Specifications & Technological Comparison Between the Welch Allyn® DuraShock™ Blood Pressure System and the Welch Allyn Tycos® Econo Blood Pressure System.
| Welch Allyn®DuraShock™ BloodPressure SystemModel ds45 | Welch Allyn®DuraShock™ BloodPressure SystemModel ds44 | Welch Allyn,Tycos® EconoBlood PressureSystem. | |
|---|---|---|---|
| Blood Pressure | |||
| BP DeterminationMethod | Non-invasive | Non-invasive | Non-invasive |
| Initial CuffInflation | Operator dependentcapable of inflation to300 mmHg. | Operator dependentcapable of inflation to300 mmHg. | Operator dependentcapable of inflation to300 mmHg. |
| Inflation/Deflation | Black NeopreneManual Bulb, MetalValve, & Black TPRTubing | Gray PVC ManualBulb, Plastic Valve,& Gray TPR Tubing | Black NeopreneManual Bulb, MetalValve, & Black TPRTubing |
| Movement | Spring Driven | Spring Driven | Gear Driven |
| MeasurementRange | |||
| Systolic | 20-300 mmHg | 20-300 mmHg | 20-300 mmHg |
| Diastolic | 20-300 mmHg | 20-300 mmHg | 20-300 mmHg |
| MeasurementAccuracy | |||
| Cuff Pressure | +/- 3 mmHg | +/- 3 mmHg | +/- 3 mmHg |
| Blood Pressure | AAMI SP9-1994 | AAMI SP9-1994 | AAMI SP9-1994 |
| Measurement time(sec.) | 30-60 sec. Typical | 30-60 sec. Typical | 30-60 sec. Typical |
| Overall System | |||
| Patient Population | Pediatric/Adult | Pediatric/Adult | Pediatric/Adult |
| Display Type | Dial | Dial | Dial |
| Warranty | Ten Years | Five Years | Ten Years |
| DuraShock™Gauge: | |||
| Length | 2.1 inches (5.33 cm) | 2.1 inches (5.33 cm) | 3.75 inches (9.525cm) |
| Width | 2.1 inches (5.33 cm) | 2.1 inches (5.33 cm) | 2.35 inches (5.97 cm) |
| Height | 0.85 inches (2.16 cm) | 0.85 inches (2.16 cm) | 1.25 inches (3.18 cm) |
| Weight | 0.10 lb. (45.36 g) | 0.10 lb. (45.36 g) | 0.35 lb. (158.76 g) |
| Protective Bumper | Yes (Black & Gray) | Yes (Multi-Color) | No |
| Cuff: | Durable IntegratedOne Piece withDuraShock™ Port | Durable IntegratedOne Piece withDuraShock™ Port | One Piece Cuff withno DuraShock™ Port |
| Cuff Sizes | Lg. Adult, Adult, Sm. | Lg. Adult, Adult, Sm. | Thigh, Lg. Adult, |
| (Available) | Adult, Child | Adult, Child | Adult, Sm. Adult,Child, Sm. Child,Infant, Newborn |
| Point ofAttachment | Inserted Directly intoBladder Section ofCuff | Inserted Directly intoBladder Section ofCuff | Attaches to Hose Portof Cuff via Length ofTPR/PVC Tubing |
| OperatingConditions | |||
| OperatingTemperature | 0 to 46 °C | 0 to 46 °C | 0 to 46 °C |
| Humidity Range | 0 to 85% RH non-condensing | 0 to 85% RH non-condensing | 0 to 85% RH non-condensing |
| StorageTemperature | -34 to 70 °C | -34 to 70 °C | -34 to 70 °C |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling an abstract bird.
AUG 1 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David A. Young II Quality Assurance engineer Welch Allyn, Inc. 95 Old Shoals Road Arden, NC 28704
K012455 Re:
Device Name: DuraShock Blood Pressure System Regulation Number: 870.1120 Regulatory Class: Class II (two) Product Code: DXQ Dated: July 9, 2001 Received: August 1, 2001
Dear Mr. Young:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. David A. Young II
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nvellicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 609110 for questions on the promotion and advertising of your device, (1) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
collefo
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement VII.
| 510(k) Number: | Unknown |
|---|---|
| Device Name: | Welch Allyn® DuraShock™ Blood Pressure System |
| Indications for use: | The DuraShock™ Blood Pressure System is intended for the non-invasive blood pressure measurement of adult and pediatricpatients. The device is not designed, sold or intended for useexcept as indicated. The Welch Allyn® DuraShock™ BloodPressure System is not designed for use with neonates. To ensurepediatric blood pressure accuracy and safety, note that the WelchAllyn® DuraShock™ child is the smallest cuff approved for usewith children and infants whose arm circumference fit within therange markings on the cuff. |
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
Or Over-The-Counter Use_
(Per 21 CFR 801.109)
Ostrich
Division of Cardiovascutar & Respiratory Devices
510(k) Number Kolaus
§ 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).