(36 days)
The SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures tor resection, transection, creation of anastomoses, for open occlusion of the heart's left atrial appendage.
The devices described here are reloadable Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. The SLS55B4 DLUs are designed to place two, double-staggered rows of titanium staples in various types of tissues. The SLS55B4 DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together.
This 510(k) pertains to a modification of an existing device (SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads) where the only change is an expansion of the "Indications for Use" to include "open occlusion of the heart's left atrial appendage." The document explicitly states that the device itself is "identical to the predicate devices (K030653)" and that "the fundamental scientific technology is identical."
Therefore, the submission does not contain a new study proving the device meets acceptance criteria for its physical performance. Instead, the focus is on demonstrating substantial equivalence for the expanded indication. Since the device's design and mechanism of action for stapling remain unchanged, the original performance data from the predicate device would be referenced or considered implicitly sufficient.
Given this context, I cannot extract information about a new acceptance criteria study, sample sizes, expert involvement, or adjudication methods directly related to this 510(k) for device performance. The only 'acceptance criterion' that can be inferred is that the expanded indication for use does not compromise the established safety and effectiveness of the identical device.
However, I can provide the available information based on the document's content, noting the absence of a new performance study for this specific 510(k submission):
1. Table of Acceptance Criteria and Reported Device Performance
As per the 510(k) submission, the device in question (SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads) is "identical" to its predicate device (K030653). The submission does not detail new performance acceptance criteria or study results for the device's physical function. The acceptance criteria for the expanded indication likely revolve around demonstrating that the device's existing and unchanged stapling capability is suitable for the new anatomical application.
Since no new performance data is presented in this 510(k) submission due to device identicality, a table of new acceptance criteria and new reported device performance cannot be generated from the given text.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate. The submission focuses on expanding indications, not re-testing the device's core performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate.
4. Adjudication Method for the Test Set
Not applicable for a new performance test set, as the device's physical design and technology are identical to the predicate.
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 stapler, not an AI-assisted diagnostic or imaging tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical stapler, not an AI-assisted diagnostic or imaging tool.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for a new performance test set in this submission. For the initial clearance of the predicate device (K030653), ground truth for performance would typically be established through mechanical testing, simulated use, and potentially in vivo animal studies, with assessment against design specifications and clinical outcomes. This submission relies on the established ground truth of the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary based on the provided document:
The K040398 submission is a Traditional 510(k) for an expanded indication for use of an already cleared device. The device itself is stated to be "identical" to its predicate (K030653). Therefore, this submission does not contain new studies on the device's core performance or new acceptance criteria for its physical function. The substantial equivalence determination for this 510(k) is based on the device's identicality to the predicate and the safety/effectiveness of its existing technology for the newly indicated use.
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Pi/2
Section E
MAR 2 4 2004
Traditional 510(k) - Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
- Submitter Information:
Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax
Applicant:
Barbara J. Whitman
February 13, 2004 Date of Notification:
-
- Name of Device:
| Trade Name: | SurgASSIST®Straight Linear 4 Row No Knife DLUswith Reloads |
|---|---|
| Common Name: | Linear Staplers with Implantable Staplesand Reloads |
| ClassificationName: | Staple, Implantable, GDW |
-
- Predicate Devices:
- a. SurgASSIST® Straight Linear Stapler Digital Loading Units® with Reloads and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. REF SLS55B, SLSR55B, SLS55G, SLSR55G, SLS55B4 and SLSR55B4 (K030653).
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4) Device Description:
The devices described here are reloadable Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. The SLS55B4 DLUs are designed to place two, double-staggered rows of titanium staples in various types of tissues. The SLS55B4 DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together.
-
- Device Modification
The Straight Linear 4 Row No Knife Digital Loading Units® are identical to the predicate devices (K030653). The only changes are in the "Indications For Use" statement. The specific change is to include the application of the device for open occlusion of the heart's left atrial appendage.
- Device Modification
-
- Indications For Use
The SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, for open occlusion of the heart's left atrial appendage.
- Indications For Use
-
- Comparison to Predicate Devices
The Straight Linear 4 Row No Knife Digital Loading Units® with Reloads are identical to the previously cleared predicate Straight Linear 4 Row No Knife Digital Loading Units® with Reloads (K030653). We have expanded the Indications For Use, but the fundamental scientific technology is identical. Please refer to Section J for predicate comparison chart.
- Comparison to Predicate Devices
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three curved lines, possibly representing a stylized bird or a flame.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4, 2004
Ms. Barbara Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938-1364
Re: K040398
Trade/Device Name: SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 13, 2004 Received: February 17, 2004
Dear Ms. Whitman:
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.
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Page 2 - Ms. Barbara Whitman
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K04032f
Power Medical Intervantions. Inc. SurgASSIST® Straight Linear 4 Row No Knife DLUs with Reloads
Traditional 510(k) – Expanded Indications • February 13, 2004
Section D
Indications for Use
Power Medical Interventions, Inc. New Hope, PA 18938
510(k) Number (if known):
Device Name: SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads
Indications For Use:
The SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures tor resection, transection, creation of anastomases, for open occlusion of the heart's left atrial appendage.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Muriam C. Lawrent
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040398
§ 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.