(35 days)
Not Found
No
The description focuses on a peristaltic pump and tubing for fluid delivery, with no mention of AI or ML capabilities.
No.
The device facilitates surgical procedures by providing cooling irrigation but does not directly treat a disease or condition.
No
Explanation: The device is an irrigation system used for cooling during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "stand-alone pump and pump control system" and includes a "fluid delivery device (tubing)," indicating it is a hardware system with a software component for control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide controlled, cooling irrigation during surgical procedures involving bone. This is a direct intervention on the patient during surgery.
- Device Description: The device is a pump and tubing system designed to deliver fluid to the surgical site. This is a mechanical system for fluid delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical irrigation system, which is a medical device used during a surgical procedure on a patient.
N/A
Intended Use / Indications for Use
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.
Product codes (comma separated list FDA assigned to the subject device)
HWE
Device Description
The Anspach Irrigation Pump System is a stand-alone pump and pump control system, designed to deliver a constant flow of irrigation fluid by means of a peristaltic pump.
The Irrigation Tube, (the subject of this submission), is a fluid delivery device that functions as a component of the irrigation system, to draw fluid from a standard IV bag to a 1/16" OD accessory for delivery to the operating site. Tubing size determines the available flow range for the system, while the pump RPM determines the specific flow rate within that range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the skull and spine
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 (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.
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
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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The Anspach Effort Special 510k Premarket Notification – Surgical Irrigation System: Device Modification
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | The Anspach Effort
4500 Riverside Drive
Palm Beach Gardens, FL 33410 | | JAN 16 2007 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact | Jim Banic
Senior Regulatory Affairs Specialist
The Anspach Effort
4500 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-627-1080 ext. 515
Fax. 561-625-9110
Email: jimb@anspach.com | | |
| Date Prepared | January 12, 2007 | | |
| Regulatory Name | Surgical instrument motors and accessories/attachments | | |
| Classification Name | Pump, Infusion | | |
| Product Code | HWE | | |
| Device
Classification | Class I
General, Restorative and Neurological Devices
21 CFR § 878.4820 | | |
| Predicate
Devices | Surgical Irrigation System -> K030576 | | |
| Performance Standards | There are no known standards established specifically for
an Irrigation System at this time. However, in addition to
The 1995 "Draft 510(k) Checklist for Urological Irrigation
System and Tubing Set" used in preparation of this Pre-
Market Notification. The following standards are
applicable to materials and components of the Anspach
surgical irrigation system:
- ASTM and other similar recognized material
composition-related standards - IEC 60601 and other similar recognized electrical
safety standards | | |
1
The Anspach Effort
Special 510k Premarket Notification – Surgical Irrigation System: Device Modification
| 3. | Quality System(s) in addition to US Federal
requirements: ISO9001, ISO13485. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. | Bio-safety - Cytotoxicity ISO10993-5 (EN 30993-
5) - Pre-sterilized devices only |
| 5. | ANSI/AAMI/ISO 11737-1:1995 Bio burden - Pre-
sterilized devices only |
| 6. | ANSI/AAMI/ISO 11137:1994 - Pre-sterilized
devices only |
| 7. | AMMI TIR 27: 2001 Alternative (11137) - Pre-
sterilized devices only |
| | Note: This list may not represent all applicable standards
routinely used or used specifically for surgical
irrigation systems. |
| Device Description | The Anspach Irrigation Pump System is a stand-alone
pump and pump control system, designed to deliver a
constant flow of irrigation fluid by means of a peristaltic
pump.
The Irrigation Tube, (the subject of this submission), is a
fluid delivery device that functions as a component of the
irrigation system, to draw fluid from a standard IV bag to a
1/16" OD accessory for delivery to the operating
site. Tubing size determines the available flow range for
the system, while the pump RPM determines the specific
flow rate within that range. |
| Indications for Use | Anspach Surgical Irrigation Systems are indicated for use
with Anspach Surgical Motor Systems for providing
controlled, cooling irrigation during cutting, shaping and
removal of bone, including bones of the skull and spine. |
| Technological
Characteristics | The Irrigation Tube has the same technological
characteristics as the currently available irrigation tube.
The only modification is solely in the inner and outer
diameter and the length of the tube.
The Irrigation Tube is a component of the Surgical
Irrigation System which is a delivery system of irrigation
fluids available to the surgeon. |
| Conclusion | The irrigation tube, (component to the Surgical Irrigation
System), and the subject of this submission, is substantially
equivalent to the legally marketed irrigation tube
component. |
2
Image /page/2/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 text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
The Anspach Effort, Inc. % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K063688
Trade/Device Name: Surgical Irrigation System Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: HWE Dated: December 7, 2006 Received: December 20, 2006
JAN 16 2007
Dear Mr. Banic:
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.
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 (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.
3
Page 2 - Mr. Jim Banic
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 your
FOR
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KD63684
The Anspach Effort
Special 510k Premarket Notification - Surgical Irrigation System: Device Modification
Indications for Use
510(k) Number (if known): K063688
Device Name: Surgical Irrigation System
Indications for Use:
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices Page _ of _
510(k) Number 110203688