(16 days)
NA
Not Found
No
The description focuses on mechanical components and traditional blood pressure measurement principles, with no mention of AI or ML.
No.
The DuraShock™ Blood Pressure System is intended for non-invasive blood pressure measurement and is not described as providing therapy or treatment.
Yes
The device measures non-invasively blood pressure (systolic and diastolic), which is used for diagnostic purposes.
No
The device description explicitly lists multiple hardware components: DuraShock™ Gauge, Integrated One Piece Cuff, Bulb, Valve, and Tubing. It also describes the mechanical operation of the gauge.
Based on the provided text, the DuraShock™ Blood Pressure System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- DuraShock™ Function: The description clearly states that the DuraShock™ Blood Pressure System is a non-invasive blood pressure measurement device. It measures blood pressure externally on the arm.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient.
Therefore, the DuraShock™ Blood Pressure System falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Adult and pediatric patients. Not designed for use with neonates.
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Welch Allyn, Tycos® Econo Blood Pressure Sphygmomanometer Welch Allyn, Inc. 510(k) Document Control Number NA (predicate device is a pre-amendment device)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Kd2455
AUG 1 7 2001
510(k) Summary II.
[As described in CFR 807.92]
| Submitted by: | Welch Allyn Inc.
95 Old Shoals Road
Arden, NC 28704 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David A. Young II
Quality 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 Pressure
Sphygmomanometer
Welch Allyn, Inc.
510(k) Document Control Number NA (predicate device is
a 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
1
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.
2
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™ Blood
Pressure System
Model ds45 | Welch Allyn®
DuraShock™ Blood
Pressure System
Model ds44 | Welch Allyn,
Tycos® Econo
Blood Pressure
System. |
|----------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------|
| Blood Pressure | | | |
| BP Determination
Method | Non-invasive | Non-invasive | Non-invasive |
| Initial Cuff
Inflation | Operator dependent
capable of inflation to
300 mmHg. | Operator dependent
capable of inflation to
300 mmHg. | Operator dependent
capable of inflation to
300 mmHg. |
| Inflation/Deflation | Black Neoprene
Manual Bulb, Metal
Valve, & Black TPR
Tubing | Gray PVC Manual
Bulb, Plastic Valve,
& Gray TPR Tubing | Black Neoprene
Manual Bulb, Metal
Valve, & Black TPR
Tubing |
| Movement | Spring Driven | Spring Driven | Gear Driven |
| Measurement
Range | | | |
| Systolic | 20-300 mmHg | 20-300 mmHg | 20-300 mmHg |
| Diastolic | 20-300 mmHg | 20-300 mmHg | 20-300 mmHg |
| Measurement
Accuracy | | | |
| 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 (9.525
cm) |
| 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 Integrated
One Piece with
DuraShock™ Port | Durable Integrated
One Piece with
DuraShock™ Port | One Piece Cuff with
no 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 of
Attachment | Inserted Directly into
Bladder Section of
Cuff | Inserted Directly into
Bladder Section of
Cuff | Attaches to Hose Port
of Cuff via Length of
TPR/PVC Tubing |
| Operating
Conditions | | | |
| Operating
Temperature | 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 |
| Storage
Temperature | -34 to 70 °C | -34 to 70 °C | -34 to 70 °C |
3
4
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.
5
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
6
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 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. |
(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