(103 days)
No
The provided text describes a mechanical pain pump with various flow rate options and accessories. There is no mention of AI, ML, or any computational analysis of data to inform device operation.
Yes
The device is intended to deliver medication for pain management and regional anesthesia, which are therapeutic medical interventions.
No
Explanation: The SmartBlock™ Pain Pump is designed to deliver medication for pain management, not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device description explicitly lists multiple hardware components, including a compression unit, solution reservoir, syringe, wound dressing, labels, carry pouch, and an optional FlowSpliter™. This indicates it is a physical medical device with hardware components, not solely software.
Based on the provided information, the SmartBlock™ Pain Pump 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 (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- SmartBlock™ Function: The SmartBlock™ Pain Pump is a device designed to deliver medication directly to or around surgical wound sites and nerves for pain management. It is an infusion pump that administers drugs into the body.
- Lack of Specimen Analysis: The description of the SmartBlock™ Pain Pump does not mention any analysis of biological specimens. Its function is purely drug delivery.
Therefore, the SmartBlock™ Pain Pump falls under the category of a therapeutic device, specifically a drug delivery system, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
Product codes
MEB
Device Description
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
The SmartBlock™ device comprises of the following components:
-
Compression unit including solution reservoir (up to 500 ml)
-
SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)
-
50/60 cc disposable svringe
-
Wound dressing
-
Medication labes
-
Pump lables
-
Carry pouch
-
FlowSpliter™ (optional)
The SmartBlock™ Pain Pump is designed for the following flow rate options:
| Reference # | Flow Rate Range | Bolus Feature | |
|---|---|---|---|
| 1 | P49520 | 1-6 ml/hr | Included |
| 2 | P49524 | 5-15 ml/hr | Included |
| 3 | P49530 | 1-6 ml/hr | Not included |
| 4 | P49534 | 5-15 ml/hr | Not included |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical wound sites and/or close proximity to nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a teardrop shape incorporated into the 'f'. The text 'Medical Flow Systems Ltd.' is written below the letters.
P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com
510(k) Summary:
SmartBlock™ Pain Pump
Company Name: Medical Flow Systems Ltd.
NOV 0 6 2007
Contact Person:
Ofer Shai Managing Director
Phone: +972-4-980-9193 +972-4-980-8356 Fax: E-mail: ofrs@mfs-medical.com
Authorized US Agent:
Mark Dollinger - President Trendlines America 2940 West, 123rd Terrace Leawood, Kansas 66200
Phone: (913) 317-8788 Fax: (913) 317-8788 E-mail: mark@trlines.com
Date prepared: July 20, 2007
Trade Name: SmartBlock™ Pain Pump
Classification name: Pump, infusion
Common/usual name: Disposable Pain Management System
Product Code: MEB
Regulation No .: 880.5725
Class: II Panel identification: General Hospital Panel
1
Image /page/1/Picture/0 description: The image shows a logo with the letters 'mfs' in a stylized font. The 'm' is in lowercase, while the 'f' and 's' are in uppercase. A teardrop shape is positioned below the 'f', creating a unique design element. Below the logo, the text 'Medical Flow Systems Ltd' is printed in a smaller font, indicating the name of the company or organization associated with the logo.
P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com
Predicate Device:
On-Q Pump, I-Flow Corp. 20202 Widrow Dr., Lake Forest, CA 92630, cleared under 510(k) no. K063530.
Description of the device:
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
The SmartBlock™ device comprises of the following components:
-
Compression unit including solution reservoir (up to 500 ml)
-
SmartInfuser regulating set (several versions of flow rate ranges, with or without MultiBolus™)
-
50/60 cc disposable svringe
-
Wound dressing
-
Medication labes
-
Pump lables
-
Carry pouch
-
FlowSpliter™ (optional)
The SmartBlock™ Pain Pump is designed for the following flow rate options:
| Reference # | Flow Rate Range | Bolus Feature | |
|---|---|---|---|
| 1 | P49520 | 1-6 ml/hr | Included |
| 2 | P49524 | 5-15 ml/hr | Included |
| 3 | P49530 | 1-6 ml/hr | Not included |
| 4 | P49534 | 5-15 ml/hr | Not included |
Indications for Use:
The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
2
Image /page/2/Picture/0 description: The image shows a logo for Medical Flow Systems Ltd. The logo consists of the letters 'mfs' in a stylized font, with a water droplet replacing the dot on the 'i'. The text 'Medical Flow Systems Ltd.' is written below the logo in a smaller font.
P.O.Box 26, Shlomi 22832, Israel ● Tel: +972-4-9808280 ● Fax: +972-4-9875565 E-mail: info@mfs-medical.com ● www.mfs-medical.com
Substantial Equivalence:
The SmartInfuser PainPump™ has the same intended use as the On-Q Pump, cleared under 510(k) no. K063530and has equivalent performance characteristics. It is therefore substantially equivalent to that device.
Conclusion -
The evaluation of the SmartBlock™ Pain Pump does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and a serpent winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2007
Medical Flow Systems, Limited C/O Mr. Mark Dollinger President Treadlines America 2940 West 123rd Terrace Leawood, Kansas 66200
Re: K072053
Trade/Device Name: SmartBlock™ Pain Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEB Dated: September 23, 2007 Received: September 25, 2007
Dear Mr. Dollinger:
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 may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Dollinger
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 (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.
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) 276-0115. 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.
Neil R. P. Ogden
Chiu Lin, Ph.D. Ja Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number (if known): | K072053 |
|---|---|
| Device Name: | SmartBlock™ Pain Pump |
| Indications for Use: | The SmartBlock™ Pain Pump is intended to provide continuous and/or intermittent delivery of medication to/or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural. |
Prescription Use X OR (Part 21 CFR 801 Subpart D)
Over the Counter Use (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)
(Division Sign-Off)
( Infection Control Anosthesionogy, Gene
510(k) Number: _______________________________________________________________________________________________________________________________________________________________