(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.
§ 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.