(35 days)
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.
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.
The provided document, K063688, describes a 510(k) premarket notification for a device modification to a Surgical Irrigation System. This submission is for a device modification, specifically to the Irrigation Tube, and primarily relies on substantial equivalence to a predicate device (K030576). It does not contain an independent study with "acceptance criteria" and "reported device performance" in the typical sense of a clinical or performance study that would generate sensitivity, specificity, or similar metrics for a diagnostic device.
The document focuses on demonstrating that the modified irrigation tube maintains the same technological characteristics and intended use as the predicate device, with the only change being in its inner diameter, outer diameter, and length. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not applicable to this type of submission.
Here's the information extracted from the document, addressing the prompt's request where applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a device modification for an irrigation tube, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device and adherence to relevant standards for materials and safety. There isn't a performance table with specific numerical metrics like accuracy or sensitivity for this type of device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Technological Characteristics: The modified Irrigation Tube must have the same fundamental technological characteristics as the currently available irrigation tube. | 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. |
| Material Composition and Biocompatibility: Materials must meet recognized standards. Bio-safety and bioburden for pre-sterilized devices. | - ASTM and other similar recognized material composition-related standards. - Bio-safety - Cytotoxicity ISO10993-5 (EN 30993-5) - Pre-sterilized devices only. - ANSI/AAMI/ISO 11737-1:1995 Bio burden - Pre-sterilized devices only. - ANSI/AAMI/ISO 11137:1994 - Pre-sterilized devices only. - AAMI TIR 27: 2001 Alternative (11137) - Pre-sterilized devices only. |
| Electrical Safety (for the overall system): The system's electrical components must meet recognized safety standards. | - IEC 60601 and other similar recognized electrical safety standards. |
| Quality System Compliance: Manufacturing must adhere to established quality management systems. | - Quality System(s) in addition to US Federal requirements: ISO9001, ISO13485. |
| Functional Equivalence: The irrigation tube must function as a component of the irrigation system to deliver fluid as intended. | The Irrigation Tube 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. (This is a description of its function, implied to be equivalent to the predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is for a device modification based on substantial equivalence, not a clinical study or performance evaluation requiring a test set of data samples. The modifications are physical dimensions of the tube.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert ground truth was mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was mentioned.
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
Not applicable. This device is a surgical irrigation tube, not an AI-assisted diagnostic tool or an imaging device to be read by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical component (irrigation tube), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the context of diagnostic or AI performance, is not relevant to this submission. The "ground truth" here is adherence to engineering specifications, material standards, and functional equivalence to the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
{0}------------------------------------------------
ن ر
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 Effort4500 Riverside DrivePalm Beach Gardens, FL 33410 | JAN 16 2007 | |
|---|---|---|---|
| Contact | Jim BanicSenior Regulatory Affairs SpecialistThe Anspach Effort4500 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-627-1080 ext. 515Fax. 561-625-9110Email: jimb@anspach.com | ||
| Date Prepared | January 12, 2007 | ||
| Regulatory Name | Surgical instrument motors and accessories/attachments | ||
| Classification Name | Pump, Infusion | ||
| Product Code | HWE | ||
| DeviceClassification | Class IGeneral, Restorative and Neurological Devices21 CFR § 878.4820 | ||
| PredicateDevices | Surgical Irrigation System -> K030576 | ||
| Performance Standards | There are no known standards established specifically foran Irrigation System at this time. However, in addition toThe 1995 "Draft 510(k) Checklist for Urological IrrigationSystem and Tubing Set" used in preparation of this Pre-Market Notification. The following standards areapplicable to materials and components of the Anspachsurgical irrigation system:1. ASTM and other similar recognized materialcomposition-related standards2. IEC 60601 and other similar recognized electricalsafety standards |
{1}------------------------------------------------
The Anspach Effort
Special 510k Premarket Notification – Surgical Irrigation System: Device Modification
| 3. | Quality System(s) in addition to US Federalrequirements: 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-sterilizeddevices only |
| 7. | AMMI TIR 27: 2001 Alternative (11137) - Pre-sterilized devices only |
| Note: This list may not represent all applicable standardsroutinely used or used specifically for surgicalirrigation systems. | |
| Device Description | The Anspach Irrigation Pump System is a stand-alonepump and pump control system, designed to deliver aconstant flow of irrigation fluid by means of a peristalticpump.The Irrigation Tube, (the subject of this submission), is afluid delivery device that functions as a component of theirrigation system, to draw fluid from a standard IV bag to a1/16" OD accessory for delivery to the operatingsite. Tubing size determines the available flow range forthe system, while the pump RPM determines the specificflow rate within that range. |
| Indications for Use | Anspach Surgical Irrigation Systems are indicated for usewith Anspach Surgical Motor Systems for providingcontrolled, cooling irrigation during cutting, shaping andremoval of bone, including bones of the skull and spine. |
| TechnologicalCharacteristics | The Irrigation Tube has the same technologicalcharacteristics as the currently available irrigation tube.The only modification is solely in the inner and outerdiameter and the length of the tube.The Irrigation Tube is a component of the SurgicalIrrigation System which is a delivery system of irrigationfluids available to the surgeon. |
| Conclusion | The irrigation tube, (component to the Surgical IrrigationSystem), and the subject of this submission, is substantiallyequivalent to the legally marketed irrigation tubecomponent. |
{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
§ 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.