(160 days)
Mill Pond, Inc. Stainless Steel Suture used with the Mill Pond, Inc. Suturer has applications in gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair.
The subject device is a reuseable hand-held instrument that places stainless steel sutures in an open or minimally invasive surgical procedure. The suture material is supplied in a sterile disposable format that involves structures for dispensing the suture and for mounting this to the instrument. The device consists of a handle, a shaft, and a jaw at the end of the shaft. The jaw, which opens and closes via a manual lever on the handle, holds the tissue to be sutured. An electric switch also on the handle activates a battery-powered motor mechanism that drives the suture wire through the tissue.
The jaw is then used to grab both strands of wire near where they emanate from the tissue. A second electric switch on the handle activates another motor that rotates the jaw causing the wire ends to twist about themselves bringing the tissue together until the desired amount of tension is developed. Another manual lever on the handle is used to cut the wire. The device is now ready for the next suture.
This document is a 510(k) premarket notification for a surgical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report or performance study.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- 510(k) Summary Nature: A 510(k) summary (or premarket notification) primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated study. It describes the device, its intended use, and compares its technical aspects to existing devices.
- Lack of Performance Data: The provided text details the device's design, materials, and intended use. It does not include any sections on:
- Performance metrics (e.g., tensile strength of sutures, speed of application, clinical success rates).
- Study design (e.g., patient population, endpoints, methodology).
- Results of any clinical or non-clinical performance studies.
- Statistical analysis.
Therefore, I cannot fulfill your request for the specific information points because the provided document does not contain that level of detail regarding acceptance criteria and a study proving their fulfillment.
What the document does state (in terms of regulatory approval):
- Substantial Equivalence: The FDA has determined the device to be "substantially equivalent" (K984151) to predicate devices: Lukens® Stainless Steel Surgical Suture, U.S. Surgical Corporation Auto Suture® Powered Endoscopic GIA Stapler, and aspects of the 3M Maxi-Driver II Battery-Powered System. This means the FDA believes it is as safe and effective as these existing devices, based on the information provided in the 510(k) submission.
- Intended Use: "Surgical device to connect tissue." More specifically, the FDA letter clarifies: "abdominal wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair." The "Statement of Indications for Use" adds: "gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair."
- Material Specification: The device "may not be manufactured from any metal other than 316L stainless steel." This is a critical regulatory limitation acting as a de facto acceptance criterion for material.
- Sterilization: "Sterilization guidelines of both the instrument and the disposable will be verified according to the referenced AAMI documents." This indicates a requirement for the device to meet AAMI sterilization standards, but no data on conducted verification is provided in this summary.
- Prescription Use: The device is restricted to prescription use (21 CFR 801.109).
To obtain the information you requested, a comprehensive clinical or performance study report for this device would be necessary.
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Image /page/0/Picture/1 description: The image shows a logo for Mill Pond with the text "MILL POND" in a bold, blocky font. Above the logo, there are two dates: "4-13-1999 2:21P" and "4/28/99". The logo is black and white and appears to be scanned from a document.
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1984157
ONE STILES ROAD SUITE 104 SALEM. NH 03079 TEL 603-896-9090 FAX 603-896-9093
P. 2
510(k) Summary
11/15/98
Mill Pond, Inc Contact Person: Trade or Proprietary Name: Common or Usual Name:
Classification Name:
Gregory E. Sancoff None available at this time Stainless steel suture wire and device for applying same Suture, nonabsorbable, steel, monofilament and multifilament
Devices to Which Equivalence is Claimed
The subject device is substantially equivalent to the Lukens® Stainless Steel Surgical Suture, the U.S. Surgical Corporation Auto Suture® Powered Endoscopic GIA Stapler, and certain aspects of the 3M Maxi-Driver II Battery-Powered System.
Description of Subject Device
The subject device is a reuseable hand-held instrument that places stainless steel sutures in an open or minimally invasive surgical procedure. The suture material is supplied in a sterile disposable format that involves structures for dispensing the suture and for mounting this to the instrument. The device consists of a handle, a shaft, and a jaw at the end of the shaft. The jaw, which opens and closes via a manual lever on the handle, holds the tissue to be sutured. An electric switch also on the handle activates a battery-powered motor mechanism that drives the suture wire through the tissue.
The jaw is then used to grab both strands of wire near where they emanate from the tissue. A second electric switch on the handle activates another motor that rotates the jaw causing the wire ends to twist about themselves bringing the tissue together until the desired amount of tension is developed. Another manual lever on the handle is used to cut the wire. The device is now ready for the next suture.
MILLPOND MEDICAL RESEARCH
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Intended Use of Subject Device Surgical device to connect tissue.
Comparison of Technical Aspects
The subject device is a reuseable hand-held instrument that places stainless steel sutures in an open or minimally invasive surgical environment. The U.S. Surgical Corporation device is disposable and performs the same function except that it uses stainless steel staples that are driven into the tissue using compressed gas as a power source. The subject device uses battery-powered electric motors for the functions of moving the wire through the tissue and for twisting the wire ends together. The 3M Maxi-Driver II Battery Powered System is a reuseable hand-held instrument for machining bones that also uses an electric motor as a mechanical energy source. The 3M device and the subject device are both sterilizable. The entire U.S. Surgical Corporation device is disposable whereas only the suture material and its container and support tube are disposable with the subject device.
The staples of the U.S. Surgical Corporation device are made of small pieces of stainless steel wire that are pushed into the tissue and the ends are bent to keep the tissue in place. The subject device pushes stainless steel suture wire through tissue and twists the ends of the wire to form a continuous closed loop that holds the tissue together.
The wire material used for the subject device is 316L stainless steel which is the identical stainless steel used in the Lukens and U. S. Surgical Corporation devices.
Sterilization guidelines of both the instrument and the disposable will be verified according to the referenced AAMI documents.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Mr. Gregory E. Sancoff President and Chief Executive Officer Mill Pond, Inc. One Stiles Road, Suite 104 Salem, New Hampshire 03079
Re: K984151 Trade Name: Stainless Steel Suture and Applier Regulatory Class: II Product Code: GAQ Dated: February 19, 1999 Received: February 23, 1999
Dear Mr. Sancoff :
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure)to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification will be announced in a future Federal Register notice. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- The Mill Pond, Inc. Stainless Steel Surgical Suture is indicated for use in abdominal 1. wound closure, hernia repair, sternal closure, and certain orthopedic procedures including cerclage and tendon repair.
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- This device may not be manufactured from any metal other than 316L stainless steel. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Mill Pond, Inc. Stainless Steel surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
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Page 2 - Mr. Gregory E. Sancoff
The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
L Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
INDICATIONS
Mill Pond, Inc. Stainless Steel Suture used with the Mill Pond, Inc. Suturer has applications in gynecological, orthopedic, and general abdominal and thoracic endoscopic surgical wound closure procedures including creation of anastomoses and hernia repair.
PRESCRIPTION X
bcoley
(Division Sign-Off)
Division of General Restorative Device K98465/
510(k) Number
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.