(122 days)
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Stainless Steel Handle (non-ratcheted)
- Stainless Steel Pull Rod attached to a stainless steel jaw
- Insulation material composed of PPSU (PolyPhenylSulfone)
Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.
The provided text describes a 510(k) pre-market notification for Miltex Laparoscopic Instruments, which primarily focuses on establishing substantial equivalence to a predicate device. This type of submission generally does not include extensive performance studies with detailed acceptance criteria as would be expected for novel or high-risk devices requiring clinical trials.
Based on the provided text, here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Explicitly Stated/Implied) | Reported Device Performance |
|---|---|
| Materials commonly used in medical devices with a long history of biocompatibility. | Patient contact materials (stainless steel 420) are compliant with a long history of biocompatibility. |
| Compliance with EN 60601-2-18 for safety of endoscopic equipment. | Subject devices can withstand EN 60601-2-18: Type 2: Particular requirements for the safety of endoscopic equipment. |
| Substantial equivalence to predicate device (CooperSurgical Laparoscopic Instruments - K021237) in indications for use, material (stainless steel jaws), non-sterile sale, and monopolar electrocautery capability. | The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability. The main differences are a change in the material for the handle (stainless steel versus carbon fiber). The submitter concludes that the device is as safe and effective. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This submission is for laparoscopic instruments, and performance is demonstrated through material compliance and comparison to a predicate device, not typically through a test set of data with a specific sample size as would be found in an AI/software device.
- Data Provenance: Not applicable/Not provided. The data provided relates to material specifications and compliance with standards, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment with experts is not relevant for this type of device submission.
4. Adjudication method for the test set:
- Not applicable/Not provided.
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/Not provided. This is a physical medical instrument, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
7. The type of ground truth used:
- Not applicable/Not provided. The "ground truth" in this context is based on engineering specifications, material standards, and functional comparison to a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.
Study Proving Acceptance Criteria:
The "study" or justification for meeting acceptance criteria in this 510(k) submission is based on the following:
- Material Biocompatibility: "The patient contact materials are commonly used in medical materials. The stainless steel 420 is compliant with the long history of biocompatibility." This indicates reliance on established knowledge and historical use of the material.
- Compliance with Safety Standards: "The subject devices can withstand EN 60601-2-18: Type 2: Particular requirements for the safety of endoscopic equipment." This demonstrates the device's adherence to relevant international safety standards for endoscopic equipment.
- Substantial Equivalence to Predicate Device: The core of a 510(k) submission. The applicant states: "The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability." The main difference (handle material) is presented as a minor change that does not affect safety or effectiveness. The conclusion explicitly states that "the subject devices are as safe and effective as the predicate devices."
In summary, for these laparoscopic instruments, the "acceptance criteria" are met by demonstrating that the device uses biocompatible materials, complies with relevant safety standards, and is substantially equivalent in design, function, and intended use to an already legally marketed device (the predicate device). There are no clinical studies or AI performance metrics involved in this type of submission document.
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MAR 4 - 2005
platfor KO43D13 FDA 510(k) Pre-Market Notification Miltex Laparoscopic Instruments
510(k) Summary [as required by 21 CFR 807.87(h) and 807.92]
Date Prepared [21 CFR 807.92(a)(1)] September 14, 2004
Submitter's Information [21 CFR 807.92(a)(1)]
Lee Zagar Miltex, Incorporated 589 Davies Drive York, PA 17402
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade name is: Miltex Laparoscopic Instruments.
Common name: Monopolar Laparoscopic Instruments, Laparoscopic Grasping Forceps, Laparoscopic Dissecting Forceps, Laparoscopic Scissors, and Laparoscopic Biopsy Punch and Forceps.
Predicate Device [21 CFR 807.92(a)(3)]
- CooperSurgical Laparoscopic Instruments- CooperSurgical Incorporated-에 K021237.
The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability. The main differences are a change in the material for the handle (stainless steel versus carbon fiber).
Description of the Device [21 CFR 807.92(a)(4)]
These devices represent a family of monopolar laparoscopic instruments that consist of:
- Stainless Steel Handle (non-ratcheted) ■
- Stainless Steel Pull Rod attached to a stainless steel jaw 포
- Insulation material composed of PPSU (PolyPhenylSulfone) l
Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.
Intended Use [21 CFR 807.92(a)(5)]
The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.
{1}------------------------------------------------
K0-4327 P2-n-2
FDA 510(k) Pre-Market Notification Miltex Laparoscopic Instruments
Technological Characteristics [21 CFR 807.92(a)(6)]
ological Characteristics 21 CFR 607.72(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0)(0 the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
mance bata [21 OF 10 0011 = (21 07 10 (2) = )
The patient contact materials are commonly used in 1980 in water materials the The patient contact materials are commonly ss steel 420 is complaint with the long history of blocompanist. The staintest entress for Medical Equipment. The DIN 17442 standard for Correston V and are compliant with EN 60601-2-18 subject devices can withsiana 5000 Part 2: Particular requirements for the safety of endoscopic equipment.
Conclusion [21 CFR 807.92(b)(3)]
sion [2] " or that the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle.
Public Health Service
MAR 4 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Lee Zagar Vice President of Quality Assurance and Regulatory Affairs Miltex, Inc. 589 Davies Drive YORK PA 17402
Re: K043013
Trade/Device Name: Miltex Laparoscopic Instruments Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HET Dated: January 31, 2005 Received: February 1, 2005
Dear Mr. Zagar:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the entrobated of the enactment date of the Medical Device Amendments, or to connine. Co pror to may 20, 1978, are excordance with the provisions of the Federal Food, Drug, de necs that have been roctaoned require approval of a premarket approval application (PMA). and Cosmetto 710- (110-) that to novice, subject to the general controls provisions of the Act. The r ou may, therefore, mainer of the Act include requirements for annual registration, listing of general volitions provision gractice, 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 your device is elaborition na controls. Existing major regulations affecting your device can be it may of Subjoct to additions, 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 I Toase oe actived that I 1978 breation that your device complies with other requirements of the Act that I Drithas made a asside regulations administered by other Federal agencies. You must of any I ederal statutes unerogieements, including, but not limited to: registration and listing comply with an the rice 110 (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 007), acoming (21 CFR Part 820); and if applicable, the electronic forth in the quality by stations (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children Comments of any first of an affect started sequivalence of your dev This letter will allow you to begin marketing your actives of your device of your device to a legally
premarket notification. The FDA finding of substantial equive and your premarket notification. The FDA inding of substantial equiralence of June 1978 - 1998 - 1998 - 1994 proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regaranter.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visormance" of our responsibilities under the Act from the Act from the 807.97). You may obtain other getteral information on your respective at its toll-free number (800) Division of 301) 443-6597 or at its Internet address 058-2041 01 (52 gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 043013
510(k) Number (if known): __T
Device Name: Miltex Laparoscopic Instruments
Indications for Use:
The devices are intended to manipulate tissue, or bowel during laparoscopic The devices are intended to mampulate insue, organs, or gains and the consistery capability to dissect and coagulate tissue.
Prescription Use _
(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)
Elinor Cole Kingman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number K175
Page 1 of 1
Page 4-1
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.