(151 days)
The CSC Series Intraluminal Stapler for Single Use have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.
The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.
This document describes the 510(k) summary for three intraluminal stapler devices. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about clinical studies with human participants, expert review of data, or AI performance metrics.
Here's an analysis of the provided information concerning acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table for each proposed device against its predicate device, outlining various specifications which act as acceptance criteria. The "Proposed Device" column lists the performance or specifications of the new device, which are implicitly understood to meet the stated criteria by being "Same" or "Similar" to the predicate, with differences not affecting safety or effectiveness.
For all three devices (CSC Series, PPHplus Series, TST Series):
| Item | Acceptance Criteria (Implied by Predicate/Device Spec) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Product Code | GDW | GDW |
| Regulation No. | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Class | Class II | Class II |
| Intended Use | Specific to each device | Same as predicate (details in tables 3-1, 3-2, 3-3) |
| Operation Principle | Manual | Manual |
| Cutting Mechanism | Circular Knife | Circular Knife |
| Safety Mechanism | Indicator for appropriate closed staple height, Safety Release for preventing mis-firing | Indicator for appropriate closed staple height, Safety Release for preventing mis-firing |
| Hardness (Circular knife) | ≥380HV0.2 | ≥380HV0.2 |
| Pressure Resistance after Suturing | ≥3.6kPa | ≥3.6kPa |
| Staple Material | Unalloyed Titanium conforms to ASTM F 67-06 | Unalloyed Titanium conforms to ASTM F 67-06 |
| Stapler Materials | Stainless Steel, Polycarbonate | Stainless Steel, Polycarbonate |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Irradiation Sterilized, SAL: 10-6 |
| Endotoxin Limit | 20 EU per Product | 20 EU per Product |
| Package | Tray with Tyvek Paper | Tray with Tyvek Paper |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 |
Device-Specific Performance (Examples from tables):
-
CSC Series Intraluminal Stapler (Table 3-1):
- Outsider Diameter: 21, 25, 29, 33 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 12.7, 16.4, 20.0, 24.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 16, 20, 24, 28 (Proposed); Similar (Predicate)
- Closed Staple Height: 2.0 mm (Proposed); Similar (Predicate)
- Closed Staple Form: Image (Proposed); Same (Predicate)
-
PPHplus Series PPH Stapler (Table 3-2):
- Outsider Diameter: 33.5 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 24.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 32 (Proposed); Same (Predicate)
- Closed Staple Height: 1.3, 1.6 mm (Proposed); Similar (Predicate)
-
TST Series Tissue-Selecting Therapy Stapler (Table 3-3):
- Outsider Diameter: 31.5, 33.5, 36.5 mm (Proposed); Similar (Predicate)
- Cutting Diameter: 22.4, 24.4, 26.4 mm (Proposed); Similar (Predicate)
- Number of Staples: 30, 32, 34 (Proposed); Similar (Predicate)
- Closed Staple Height: 1.3, 1.6, 2.0 mm (Proposed); Similar (Predicate)
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These non-clinical tests include Performance Testing (Physical Specification, Closed Staple Height, Pressure Resistance, Tensile Strength, Force to Fire), Endotoxin Limit, Package Integrity, and Shelf Life.
- Sample Size for Test Set: Not explicitly stated. The tests are described generally, without specific numbers of devices or samples tested.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) and do not involve human or animal subjects in the sense of clinical trials. The country of origin for the data is implicitly the country where Touchstone International Medical Science Co., Ltd. conducts its testing, which is P.R. CHINA. The data is prospective in the sense that these tests were conducted on the newly manufactured devices to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document describes non-clinical engineering and performance testing of a medical stapler. There is no "ground truth" established by experts in the context of diagnoses or interpretations of medical images/data, as there would be for an AI device. The "ground truth" here refers to the actual measured physical properties and performance characteristics of the device during bench testing, compared against predetermined engineering specifications or predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. As described above, this is non-clinical bench testing. There is no adjudication method in the context of expert review or consensus for patient-related outcomes. The judgment is based on objective measurements and adherence to specifications.
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 document is for a surgical stapler, not an AI or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a surgical stapler, not an AI or algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests can be considered the objectively measured performance characteristics of the device itself (e.g., measured closed staple height, actual pressure resistance, force to fire, endotoxin levels). These measurements are then compared against established engineering specifications, regulatory standards (like ASTM F 67-06 for Titanium), and the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as above.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.